2006 Seprafilm Adverse Event Reports (FDA)

GENZYME BIOSURGERY/GENZYME SEPRAFILM 3 SHEETS

Event Description

Female, underwent a right salpingo-oophorectomyby the gynecology service for a fibroma. The pt was found to have adhesionsin the small bowel area and adhesiolysis was performed by a general surgeon.Three sheets of seprafilm were utilized around the small bowel. One sheetof seprafilm was placed between the retroperitoneum and the small bowel.Two sheets were placed between the small bowel and the intra abdominal wall.The pt did well with her postoperative recovery and was subsequently dischargedfour days later. Within 24 hrs of discharge, the pt was experiencing nauseaand vomiting. She was unable to tolerate any oral intake. She was not experiencingabdominal bloating or distension. She presented to the emergency dept ontwo occasions. First on the evening of the next day and then again at theearly evening the following day. She was hydrated with intravenous fluidson both occasions. Her symptoms persisted, however, and she re-presentedto the emergency dept 3 days later. She was found to have a benign abdominalexamination. Her while blood cell count, however, was elevated at 14. 95.She was clinically dehydrated with hyponatremia, hypokalemia and hypochloremia.She was admitted to the hosp for further evaluation and management. A nasogastrictube was placed. She had greater than two liters of output. A ct scan ofabdomen and pelvis was obtained revealing dilatation of the stomach and proximalsmall bowel. There was a transition point with distal decompression. Thiswas consistent with a mechanical small bowel obstruction. The next day, thept was taken to the o. R. And re-opened. The pt was found to have a veryintense inflammatory reaction of her small bowel and small bowel mesenterywere clumped together into a few areas of indurated masses. Her entire smallbowel was basically one large conglomerate that was matted together. Thetissues appeared somewhat melted together, without any identificable planes.The tissues were friable, and upon opening the abdomen, injuries were sustained.An area of "deserosalization" was oversewn. Two enterotomies were repaired.A distal ilieal longitudinal tear was not repairable. The pt basically hada "concrete abdomen" and this was inoperable. A resection was impossible,as was exteriorization. The proximal and distal portions of the tear weredecompressed with tube ileostomies. The inflammatory process was limitedto the distribution of where the seprafilm was placed. This was around thesmall bowel and small bowel mesentery. The pelvis was spared from this process,as was the upper abdomen. She was kept on bowel rest/decompression and totalparenteral nutrition. Over the next few days, the pt developed progressiveconfusion and delirium. Her oxygen requirements increased. A chest x-rayrevealed patchy infiltrates. The pt was subsequently transferred to icu 2days later. The next day, she was diagnosed with severe sepsis and begantreatment using xigris. The pt's respiratory status worsened and she eventuallyrequired intubation and ventilatory support. The pt appeared to develop asystemic inflammatory response and ards. The pt continued on high ventilatorysupport and intermittent vasopressors. It was felt that she had worsening fibroproliferative ards. Twenty days later, active measures were withdrawn and the pt subsequently passed away.


Event Date 03/23/2006 Event Type Injury Event Description

Severe adhesive intestinal obstruction. Underwent synechiotomy due to severe adhesive intestinal obstruction. In mar-2006 with placement of one sheet of seprafilm under the wounded area. No post-operative complications were noted. On 23-mar-2006 the patient developed severe adhesive intestinal obstruction under the wounded area where the seprafilm had been placed. Two days earlier the patient was getting better and considered recovered without sequelae. The physician assessed the relationship between the event and seprafilm as "definite".


Device Problem Device, incorrect care/use of Event Date 01/31/2006 Event Type Injury Event Description

Vaginal bleeding; hydrosalpinx of the right (fallopian) tube; multiple degenerating cysts of the right ovary; multiple adhesion between right ovary, omentum, and the top of the vaginal cuff; piece of plastic found in vaginal. A female pt (age and initials unk) who underwent a hysterectomy in 2003 during which seprafilm was placed (number of sheets and location unk). Two years status post hysterectomy, the pt was brought in with vaginal bleeding. Granulation tissue at the top of the vaginal felt to be a stitch granuloma was initially tried to be removed vaginally in 2004 but the to continued to have vaginal bleeding. On 31-jan-2006, the pt was brought in for a combined approach laparscopy and found to have hydrosalpinx of the right (fallopian) tube with multiple degenerating cysts of the right ovary and multiple adhesion between that, the omentum, and top of the vaginal cuff. Additionally during the procedure, a piece of plastic measuring 8. 5 x 3. 7 x 0. 1 cm was found in the area around the vaginal cuff. The plastic was removed and the area repaired. The pt tolerated the procedure well. The reporter stated that a review of ths physican properties of the plastic removed from the pt was found to be similar to a portion of the holder that is used to apply and protect the adhesion barrier (seprafilm) in the packaging. The reporter felt that in the case, it was possible that the holder was left in the pt rather than removing it per manufacturer instructions. No further details regarding the surgery or pt outcome were provided. The reporting health care professional did not ptovide an assessment of the relationship of the events to the use of seprafilm. Manufacturer's comment: no lot number was provided by the user facility. Genzyme quality assurance is unable to perform an evaluation or lot history review. Additional information was received april-2006 from the hosp risk manager who provided the initial report to fda. The risk manager stated that she believes that same surgeon had performed both the original hysterectomy procedure as well as the re-operative procedure which revealed the piece of plastic in the vaginal cuff area and led to its removal. The risk manager stated that "they were absolutely certain seprafilm had been used in the initial procedure. " she also stated that there were originally plans to do testing on the retained piece of plastic however; once it had been removed from the pt it had been placed in formaldehyde for a perios of plastic however; once it had been removed from the ot it had been placed in formaldehyde for a period of time and therefore no testing was performed. She confimred that only a physical examination of the pice of plastic was completed and it was concluded from that, that the plastic in the pt was similar to the plastic holder used in seprafilm placement.


Event Date 01/22/2006 Event Type Injury Event Description

Small bowel obstruction, small bowel matted together, inflammatory reaction of the small bowel. Information was received from a physician in 2006 concerning a patient with a pas t surgical history of an unspecified operation to correct a previous bowel obstruction, who in 2006 underwent removal of a right ovarian mass and lysis of adhesion. One sheet of seprafilm was placed between the retroperitoneum and the small bowel, and two sheets were placed between the small bowel and the entry abdominal wall. During the surgery, saline was the only fluid used for intraperitoneal irrigation, gloves were non-powdered, no products were left behind in the abdominal cavity, and sutures were silk. The reporting physician thought that the patient had no known allergies, but he was not completely sure. Three to four days post-operation, the patient developed nausea and vomiting and was unable to keep anything down. A white blood cell count was elevated at 16,000 mm3. 6 days later, a computed tomography scan showed a transition point small bowel obstruction. That same day, the patient underwent a re-operation to repair the obstruction. At re-operation, the physician discovered that the patient was experiencing an "inflammatory reaction of the small bowel" in the area of seprafilm placement. The bowel was noted to be inflamed and "matted together," which was causing her obstruction. No further details regarding the surgery or patient outcome were provided. The reporting physician felt that the events were "between highly probably and definite" related to the use of seprafilm.


Event Description

After placement of seprafilm, pt developed early postop small bowel obstruction and leukocytosis. Re-exploration-significant edema, induration, adherence, friability to tissues where seprafilm was placed (small bowel and mesentery). Abdomen was inoperable.