SEPRAFILM
Report
- Report Number
- 1220423-2015-85713
- Event Type
- Injury
- Date Received
- August 25, 2015
- Date of Event
- August 1, 2015
- Report Date
- August 17, 2015
- Manufacturer
- GENZYME BIOSURGERY (SEPRAFILM/PACK)
- Product Code
- MCN
- PMA / PMN Number
- P950034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(4) 2015 FROM A PHYSICIAN (OBSTETRICIAN/ GYNECOLOGIST). THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED PERITONITIS, HAD STRONG ADHESIONS, POSTOPERATIVE ILEUS, INCREASED C REACTIVE PROTEIN AND SEPRAFILM LIKE WHITE MOSSES WERE OBSERVED ON THE ADHESIOLYSIS SITES AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OVARIAN CANCER. ON (B)(6) 2015, THE PATIENT UNDERWENT RADICAL OVARIAN CANCER SURGERY WITH LYMPH NODE EXCISION (INITIAL SURGERY) AND 2 SHEETS OF SEPRAFILM WERE APPLIED ONCE (1 SHEET TO THE RETROPERITONEAL LYMPH NODE EXCISION SITE, AND 1 SHEET UNDER THE INCISIONAL WOUND) (ROUTE, FORMULATION, INDICATION, BATCH/LOT NUMBER AND EXPIRY DATE: NOT PROVIDED). ON UNKNOWN DATES IN 2015, (4 OR 5 DAYS AFTER THE SURGERY), THE PATIENT HAD SLIGHT FEVER, INCREASED CRP, AND ABDOMINAL PAIN. ON (B)(6) 2015, (10 DAYS AFTER THE FIRST APPLICATION OF SEPRAFILM), PERITONITIS AND POSTOPERATIVE ILEUS DEVELOPED AND THE PATIENT UNDERWENT REOPERATION ON THE DAY. IT WAS REPORTED THAT STRONG ADHESIONS WERE OBSERVED ON THE APPLICATION SITES OF SEPRAFILM (RETROPERITONEUM AND UNDER THE INCISIONAL WOUND, APPARENTLY THE APPLICATION SITES OF SEPRAFILM) AND ADHESIOLYSIS WAS PERFORMED. ALSO REPORTED THAT ADHESION WAS OBSERVED ON UMBILICAL AREA OF SEPRAFILM (FSP) APPLICATION SITE AND FSP WAS APPLIED ON THE VASCULAR SURFACE. IT WAS REPORTED THAT SEPRAFILM (FSP)-LIKE WHITE MOSSES WERE OBSERVED DURING REOPERATION AND STRONG ADHESIONS WERE NOTED AROUND THE WHITE MOSSES AND REMOVAL OF THE WHITE MOSSES AND IRRIGATION WERE PERFORMED. ON (B)(6) 2015, AS OF MORNING, THE OUTCOMES OF THE EVENTS WERE UNKNOWN. IT WAS REPORTED THAT ILEUS TUBE WAS SCHEDULED TO BE REMOVED IN THE AFTERNOON ON THE DAY. FURTHER REPORTED THAT BACTERIAL CULTURE WAS NOT PERFORMED. CORRECTIVE TREATMENT: STRONG ADHESIONS: ADHESIOLYSIS; PERITONITIS, POSTOPERATIVE ILEUS: SURGERY; SEPRAFILM LIKE WHITE MOSSES WERE OBSERVED ON THE ADHESIOLYSIS SITES: REMOVAL OF WHITE MOSSES; IRRIGATION; INCREASED C REACTIVE PROTEIN: NOT REPORTED. OUTCOME: INCREASED C REACTIVE PROTEIN, POSTOPERATIVE ILEUS, PERITONITIS AND STRONG ADHESIONS: UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND PTC RESULTS WERE PENDING. SERIOUSNESS CRITERIA: LIFE THREATENING AND REQUIRED INTERVENTION FOR PERITONITIS AND POSTOPERATIVE ILEUS; REQUIRED INTERVENTION FOR STRONG ADHESIONS. DIAGNOSIS: PERITONITIS (PERITONITIS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (LIFE-THREATENING). REPORTING OBSTETRICIAN/GYNECOLOGIST'S CAUSALITY ASSESSMENT: PROBABLE. DIAGNOSIS: POSTOPERATIVE ILEUS (POSTOPERATIVE ILEUS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (LIFE-THREATENING) REPORTING OBSTETRICIAN/GYNECOLOGIST'S COMMENT: ALLERGIC REACTION WAS CONSIDERED TO BE AN ALTERNATIVE EXPLANATION FOR THE EVENTS. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED (B)(4) 2015: THIS INITIAL CASE CONCERNS A FEMALE PATIENT WHO UNDERWENT SURGERY AND SHEETS OF SEPRAFILM WERE APPLIED AND LATER EXPERIENCED ABDOMINAL ADHESIONS. SINCE, A SIGNIFICANT TEMPORAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN PRODUCT AND EVENT START DATE AND CAUSAL ROLE OF SEPRAFILM CANNOT BE EXCLUDED IN OCCURENCE OF THE EVENT. HOWEVER, LACK OF DETAILED INFORMATION ABOUT MEDICAL HISTORY, CONCURRENT CONDITIONS AND PAST DRUGS PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 17-AUG-2015 FROM A PHYSICIAN (OBSTETRICIAN/GYNECOLOGIST). THIS CASE CONCERNS A FEMALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED PERITONITIS, HAD STRONG ADHESIONS, POSTOPERATIVE ILEUS, INCREASED C REACTIVE PROTEIN AND SEPRAFILM LIKE WHITE MOSSESS WERE OBSERVED ON THE ADHESIOLYSIS SITES AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG, CONCOMITANT MEDICATION AND CONCURRENT CONDITION WAS REPORTED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OVARIAN CANCER. ON (B)(6) 2015, THE PATIENT UNDERWENT RADICAL OVARIAN CANCER SURGERY WITH LYMPH NODE EXCISION (INITIAL SURGERY) AND 2 SHEETS OF SEPRAFILM WERE APPLIED ONCE (1 SHEET TO THE RETROPERITONEAL LYMPH NODE EXCISION SITE, AND 1 SHEET UNDER THE INCISIONAL WOUND) (ROUTE, FORMULATION, INDICATION, BATCH/LOT NUMBER AND EXPIRY DATE: NOT PROVIDED). ON UNKNOWN DATES IN 2015, (4 OR 5 DAYS AFTER THE SURGERY), THE PATIENT HAD SLIGHT FEVER, INCREASED CRP, AND ABDOMINAL PAIN. ON (B)(6) 2015, (10 DAYS AFTER THE FIRST APPLICATION OF SEPRAFILM), PERITONITIS AND POSTOPERATIVE ILEUS DEVELOPED AND THE PATIENT UNDERWENT REOPERATION ON THE DAY. IT WAS REPORTED THAT STRONG ADHESIONS WERE OBSERVED ON THE APPLICATION SITES OF SEPRAFILM (RETROPERITONEUM AND UNDER THE INCISIONAL WOUND, APPARENTLY THE APPLICATION SITES OF SEPRAFILM) AND ADHESIOLYSIS WAS PERFORMED. ALSO REPORTED THAT ADHESION WAS OBSERVED ON UMBILICAL AREA OF SEPRAFILM (FSP) APPLICATION SITE AND FSP WAS APPLIED ON THE VASCULAR SURFACE. IT WAS REPORTED THAT SEPRAFILM (FSP)-LIKE WHITE MOSSES WERE OBSERVED DURING REOPERATION AND STRONG ADHESIONS WERE NOTED AROUND THE WHITE MOSSES AND REMOVAL OF THE WHITE MOSSES AND IRRIGATION WERE PERFORMED. ON (B)(6) 2015, AS OF MORNING, THE OUTCOMES OF THE EVENTS WERE UNKNOWN. IT WAS REPORTED THAT ILEUS TUBE WAS SCHEDULED TO BE REMOVED IN THE AFTERNOON ON THE DAY. FURTHER REPORTED THAT BACTERIAL CULTURE WAS NOT PERFORMED. CORRECTIVE TREATMENT: STRONG ADHESIONS: ADHESIOLYSIS; PERITONITIS, POSTOPERATIVE ILEUS: SURGERY; SEPRAFILM LIKE WHITE MOSSESS WERE OBSERVED ON THE ADHESIOLYSIS SITES: REMOVAL OF WHITE MOSSESS; IRRIGATION; INCREASED C REACTIVE PROTEIN: NOT REPORTED. OUTCOME: INCREASED C REACTIVE PROTEIN, POSTOPERATIVE ILEUS, PERITONITIS AND STRONG ADHESIONS : UNKNOWN. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). ON 17-AUG-2015, GENZYME RECEIVED PRE-AE EVENT (B)(4) REGARDING A PATIENT WHO HAD SEPRAFILM USED DURING SURGERY AND DEVELOPED ADHESIONS AT THE SITES OF APPLICATION. NO LOT NUMBER WAS RECEIVED IN THE INITIAL INTAKE INFORMATION. AN ADDITIONAL REQUEST WAS MADE ON 25- AUG-2015, CONFIRMATION FROM THE REPORTER ON 27- AUG-2015 STATED THAT A LOT NUMBER WAS NOT AVAILABLE FOR THE EVENT AND THAT IF A LOT NUMBER WAS RECEIVED IT WOULD BE SENT AS ADDITIONAL INFORMATION. SINCE NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; GENZYME BIOSURGERY QUALITY ASSURANCE WAS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY GENZYME WERE RELEASED FOR SHIPMENT BY QUALITY ASSURANCE ONLY AFTER SUCCESSFUL COMPLETION OF QUALITY CONTROL CERTIFICATE OF ANALYSIS TESTING AND REVIEW OF ALL DEVICE HISTORY RECORDS AND ASSOCIATED MANUFACTURING PROCESS DOCUMENTATION. THIS LOT RELEASE PROCEDURE PROVIDED ASSURANCE THAT ALL PRODUCT LOTS WERE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASSED FINAL PRODUCT SPECIFICATIONS. SEPRAFILM ADHESION BARRIER WAS PACKAGED IN A TYVEK HOLDER WITHIN A PLASTIC SLEEVE AND SEALED IN AN OUTER FOIL POUCH. THE CONTENTS OF THE FOIL POUCH WERE STERILIZED BY GAMMA RADIATION. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/(B)(4) GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WOULD BE DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT WAS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WOULD BE REOPENED AND AN INVESTIGATION WOULD BE PERFORMED BY GENZYME-(B)(4) BIOSURGERY QUALITY ASSURANCE AT THAT TIME. SERIOUSNESS CRITERIA: LIFE THREATENING AND REQUIRED INTERVENTION FOR PERITONITIS AND POSTOPERATIVE ILEUS; REQUIRED INTERVENTION FOR STRONG ADHESIONS. DIAGNOSIS: PERITONITIS (PERITONITIS); REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (LIFE-THREATENING); REPORTING OBSTETRICIAN/GYNECOLOGIST'S CAUSALITY ASSESSMENT: PROBABLE. DIAGNOSIS: POSTOPERATIVE ILEUS (POSTOPERATIVE ILEUS); REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (LIFE-THREATENING). REPORTING OBSTETRICIAN/GYNECOLOGIST'S COMMENT: ALLERGIC REACTION WAS CONSIDERED TO BE AN ALTERNATIVE EXPLANATION FOR THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 28-AUG-2015: GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: (B)(4) FOLLOW UP COMPANY COMMENT DATED: 28-AUG-2015: FOLLOW UP INFORMATION RECEIVED, DOES NOT CHANGE PREVIOUS CASE ASSESSMENT. (B)(4) COMMNET DATED 21-AUG-2015: THIS INITIAL CASE CONCERNS A FEMALE PATIENT WHO UNDERWENT SURGERY AND SHEETS OF SEPRAFILM WERE APPLIED AND LATER EXPERIENCED ABDOMINAL ADHESIONS. SINCE, A SIGNIFICANT TEMPORAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN PRODUCT AND EVENT START DATE AND CAUSAL ROLE OF SEPRAFILM CANNOT BE EXCLUDED IN OCCURENCE OF THE EVENT. HOWEVER, LACK OF DETAILED INFORMATION ABOUT MEDICAL HISTORY, CONCURRENT CONDITIONS AND PAST DRUGS PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 17-AUG-2015 FROM A PHYSICIAN (OBSTETRICIAN/ GYNECOLOGIST). THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WHO EXPERIENCED PERITONITIS, HAD STRONG ADHESIONS, ASCITES, VAGINAL STUMP DEHISCENCE/ ABDOMINAL WALL WOUND DEHISCENCE, PSEUDOMONAS AERUGINOSA WAS ISOLATED, POSTOPERATIVE ILEUS, WBC WERE HIGH AND SEPRAFILM LIKE WHITE MOSSESS WERE OBSERVED ON THE ADHESIOLYSIS SITES AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG AND CONCURRENT CONDITION WAS REPORTED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OVARIAN CANCER. THE PATIENT HAD NO HISTORY OF DIABETES MELLITUS, ALLERGY, ANAEMIA, SURGERY AND RADIOTHERAPY. THE PATIENT WAS A NON-SMOKER. THE CONCOMITANT DRUG INCLUDED LOXOPROFEN AS PREVENTIVE TREATMENT FOR POSTOPERATIVE PAIN. ON (B)(6) 2015, THE PATIENT WAS HOSPITALIZED FOR SURGERY. SHE WAS RECEIVING NO CONCOMITANT DRUGS. ON (B)(6) 2015, THE PATIENT UNDERWENT RADICAL OVARIAN CANCER SURGERY WITH LYMPH NODE EXCISION (INITIAL SURGERY) WHICH WAS AN ELECTIVE SURGERY AND 2 SHEETS OF SEPRAFILM WERE APPLIED ONCE (1 SHEET TO THE RETROPERITONEAL LYMPH NODE EXCISION SITE, AND 1 SHEET UNDER THE INCISIONAL WOUND) UNDER THE ABDOMINAL WALL INCISION WOUND (ROUTE, FORMULATION, INDICATION, BATCH/LOT NUMBER AND EXPIRY DATE: NOT PROVIDED). THE CONDITION OF APPLICATION WAS FAVORABLE. NO PRE-EXISTING ADHESION WAS OBSERVED. NO PREEXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION (2 L) WAS PERFORMED. RESECTION (TOTAL HYSTERECTOMY, BILATERAL ADNEXECTOMY, PARTIAL OMENTECTOMY, PELVIC AND PARA-AORTIC LYMPH NODE EXCISION) WAS PERFORMED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE RESECTION SITES. THE RESECTION SITES WERE ANASTOMOSED WITH HAND SUTURE (INTERRUPTED ANASTOMOSIS). OPERATIVE FIELD WAS CLEAN. THE LENGTH OF LAPAROTOMY INCISION WAS 25 CM, AND INVOLVED SATURATION OF 3 LAYERS. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. THE FIRST LAYER (PERITONEUM) WAS SUTURED WITH ABSORBABLE, SYNTHETIC MONO THREAD (INTERRUPTED ANASTOMOSIS). THE SKIN WAS ANASTOMOSED WITH HAND SUTURE USING ABSORBABLE, SYNTHETIC MONO THREAD (INTERRUPTED ANASTOMOSIS). THE OPERATIVE TIME WAS APPROXIMATELY 6 HOURS. THE VOLUME OF HAEMORRHAGE WAS 1065 G AND AUTOLOGOUS BLOOD TRANSFUSION WAS PERFORMED. DRAINAGE TUBE (J-VAC) WAS PLACED TO THE PELVIC FLOOR ON THE DAY (CLOSED DRAIN), AND THE DRAINAGE CONDITION IMMEDIATELY AFTER THE PLACEMENT WAS FAVORABLE. ON (B)(6) 2015, THE PATIENT STARTED TREATMENT WITH ORAL LOXOPROFEN (TWICE A DAY OR THRICE A DAY) FOR POSTOPERATIVE PAIN. ON (B)(6) 2015 (POSTOPERATIVE DAY [POD] 3), THE TUBE WAS REMOVED. SECOND LOOK LAPAROSCOPY WAS NOT PERFORMED. THE SAME DAY, SLIGHT FEVER IN THE 37 DEGREE CELSIUS PERSISTED. ON (B)(6) 2015, WHITE BLOOD CELL (WBC) AND C - REACTIVE PROTEIN (CRP) WERE HIGH (10,100/MM3 AND 10.98 MG/DL, RESPECTIVELY). ON (B)(6) 2015, 5 DAYS AFTER APPLYING SEPRAFILM, MODERATE PERITONITIS DEVELOPED. THE EVENT WAS CONFIRMED ON COMPUTED TOMOGRAPHY CT AND PHYSICAL EXAMINATION. THE ABDOMINAL WALL WOUND DEHISCENCE OF 2 CM WAS NOTED. SHE HAD DIARRHOEA, ABDOMINAL PAIN AND VOMITING. THE SAME DAY, SHE STARTED L TREATMENT WITH ORAL CLOSTRIDIUM BUTYRICUM (MIYA-BM) AT 1 PACKET THRICE A DAY FOR THE DIARRHOEA. ON (B)(6) 2015, THE PATIENT STARTED TREATMENT WITH DICLOFENAC SODIUM SUPPOSITORY (RECTAL) DAILY FOR THE ABDOMINAL PAIN. THE SAME DAY, 6 DAYS AFTER APPLYING SEPRAFILM, SEVERE ILEUS DEVELOPED. THE EVENT WAS CONFIRMED ON X-RAY AND CT. THE DIAGNOSIS OF ILEUS WAS MADE ON THE DAY BASED ON X-RAY, WHICH WAS PERFORMED FOR THE PERSISTED VOMITING. CONSERVATIVE THERAPY (NIL PER ORAL) WAS STARTED. THE VAGINAL STUMP DEHISCENCE WAS NOTED, AND EFFUSION WHICH WAS PROBABLY ASCITES FLOWED OUT FROM THE VAGINA. ON (B)(6) 2015, THE TREATMENT WITH CLOSTRIDIUM BUTYRICUM WAS COMPLETED. ON (B)(6) 2015, THE TREATMENT WITH DICLOFENAC SODIUM WAS COMPLETED. ON (B)(6) 2015, THE ILEUS WAS AGGRAVATED WITH THE CONSERVATIVE THERAPY, AND INSERTION OF ILEUS TUBE WAS TRIED CONSULTING WITH THE SURGICAL DEPARTMENT BUT THE INSERTION WAS IMPOSSIBLE BECAUSE THE STENOSIS WAS TOO SEVERE. IT WAS REPORTED THAT STRONG ADHESIONS WERE OBSERVED ON THE APPLICATION SITES OF SEPRAFILM (RETROPERITONEUM AND UNDER THE INCISIONAL WOUND, APPARENTLY THE APPLICATION SITES OF SEPRAFILM) AND ADHESIOLYSIS WAS PERFORMED. ALSO REPORTED THAT ADHESION WAS OBSERVED ON UMBILICAL AREA OF SEPRAFILM (FSP) APPLICATION SITE AND FSP WAS APPLIED ON THE VASCULAR SURFACE. THEREFORE, EMERGENCY SURGERY (RELAPAROTOMY) WAS PERFORMED ON THE DAY. LEVIGATED RESIDUAL SEPRAFILM (FSP)-LIKE WHITE MOSSES) WAS OBSERVED (STRONG ADHESIONS WERE NOTED AROUND THE WHITE MOSSES) AND REMOVED (SWABBED WITH GAUZE). RELEASE OF ILEUS WAS ALSO PERFORMED. THE EVENTS REMARKABLY IMPROVED AFTER THE RELAPAROTOMY. THE SAME DAY, THE PUS CULTURE OF ASCITES WAS PERFORMED (COLLECTED DURING RELAPAROTOMY) FOR GENERAL AEROBES, GENERAL ANAEROBES, AND PSEUDOMONAS AERUGINOSA. THE PSEUDOMONAS AERUGINOSA WAS ISOLATED. THE SAME DAY, WBC WAS 11,100/MM3 AND CRP WAS 26.7 MG/DL. NO HISTOLOGICAL EXAMINATION WAS PERFORMED. ON (B)(6) 2015, AS OF MORNING, THE OUTCOMES OF THE EVENTS WERE UNKNOWN. IT WAS REPORTED THAT ILEUS TUBE WAS SCHEDULED TO BE REMOVED IN THE AFTERNOON ON THE DAY. BACTERIAL CULTURE WAS NOT PERFORMED. ON (B)(6) 2015, THE EVENTS OF PERITONITIS AND POSTOPERATIVE ILEUS RESOLVED. THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO EVENTS. SHE WAS NOT READMITTED FOR THE TREATMENT. CORRECTIVE TREATMENT: STRONG ADHESIONS: ADHESIOLYSIS; PERITONITIS: SURGERY; SEPRAFILM LIKE WHITE MOSSES WERE OBSERVED ON THE ADHESIOLYSIS SITES: REMOVAL OF WHITE MOSSES; IRRIGATION; SURGERY, CONSERVATIVE THERAPY (NIL PER OS) AND RELAPAROTOMY FOR POSTOPERATIVE ILEUS; DICLOFENAC SODIUM SUPPOSITORY FOR ABDOMINAL PAIN; NOT REPORTED FOR ASCITES, PSEUDOMONAS AERUGINOSA WAS ISOLATED, VAGINAL STUMP DEHISCENCE/ ABDOMINAL WALL WOUND DEHISCENCE AND WBC WERE HIGH OUTCOME: RECOVERED/ RESOLVED FOR POSTOPERATIVE ILEUS AND PERITONITIS; UNKNOWN FOR PSEUDOMONAS AERUGINOSA WAS ISOLATED, ASCITES, VAGINAL STUMP DEHISCENCE/ ABDOMINAL WALL WOUND DEHISCENCE, WBC WERE HIGH AND STRONG ADHESIONS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). ON 17-AUG-2015, GENZYME RECEIVED PRE-AE EVENT (B)(4) REGARDING A PATIENT WHO HAD SEPRAFILM USED DURING SURGERY AND DEVELOPED ADHESIONS AT THE SITES OF APPLICATION. NO LOT NUMBER WAS RECEIVED IN THE INITIAL INTAKE INFORMATION. AN ADDITIONAL REQUEST WAS MADE ON 25- AUG-2015, CONFIRMATION FROM THE REPORTER ON 27- AUG-2015 STATED THAT A LOT NUMBER WAS NOT AVAILABLE FOR THE EVENT AND THAT IF A LOT NUMBER WAS RECEIVED IT WOULD BE SENT AS ADDITIONAL INFORMATION. SINCE NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; GENZYME BIOSURGERY QUALITY ASSURANCE WAS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY GENZYME WERE RELEASED FOR SHIPMENT BY QUALITY ASSURANCE ONLY AFTER SUCCESSFUL COMPLETION OF QUALITY CONTROL CERTIFICATE OF ANALYSIS TESTING AND REVIEW OF ALL DEVICE HISTORY RECORDS AND ASSOCIATED MANUFACTURING PROCESS DOCUMENTATION. THIS LOT RELEASE PROCEDURE PROVIDED ASSURANCE THAT ALL PRODUCT LOTS WERE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASSED FINAL PRODUCT SPECIFICATIONS. SEPRAFILM ADHESION BARRIER WAS PACKAGED IN A TYVEK HOLDER WITHIN A PLASTIC SLEEVE AND SEALED IN AN OUTER FOIL POUCH. THE CONTENTS OF THE FOIL POUCH WERE STERILIZED BY GAMMA RADIATION. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WOULD BE DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT WAS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WOULD BE REOPENED. AND AN INVESTIGATION WOULD BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME. SERIOUSNESS CRITERIA: LIFE THREATENING AND REQUIRED INTERVENTION FOR POSTOPERATIVE ILEUS; REQUIRED INTERVENTION FOR STRONG ADHESIONS; HOSPITALIZATION AND PROLONGATION FOR ASCITES, VAGINAL STUMP DEHISCENCE/ ABDOMINAL WALL WOUND DEHISCENCE AND PSEUDOMONAS AERUGINOSA WAS ISOLATED; REQUIRED INTERVENTION AND HOSPITALIZATION/PROLONGATION FOR PERITONITIS. DIAGNOSIS: PERITONITIS (PERITONITIS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/ PROLONGED HOSPITALIZATION). REPORTING OBSTETRICIAN/GYNECOLOGIST'S CAUSALITY ASSESSMENT: PROBABLE. DIAGNOSIS: POSTOPERATIVE ILEUS (POSTOPERATIVE ILEUS). REPORTING OBSTETRICIAN/GYNECOLOGIST'S SERIOUSNESS ASSESSMENT: SERIOUS (LIFE-THREATENING). REPORTING OBSTETRICIAN/GYNECOLOGIST'S COMMENT: ALLERGIC REACTION WAS CONSIDERED TO BE AN ALTERNATIVE EXPLANATION FOR THE EVENTS. ANOTHER CAUSATIVE FACTOR FOR THE EVENT WAS SURGERY INVASION OR CONCOMITANTLY USED MEDICAL DEVICE (INCLUDING SUTURE THREAD AND DRAIN TUBE). WHITE MOSS-LIKE SUBSTANCE, WHICH WAS PROBABLY RESIDUE OF SEPRAFILM, WAS OBSERVED ON THE AREAS WHICH WERE THE SEPRAFILM APPLICATION SITES. ALL THE APPLICATIONS SITES HAD INTENSIVE INFLAMMATION OF SURROUNDING AREAS, AND INTENSIVE ADHESION WAS OBSERVED AROUND THOSE SITES. THEREFORE, THERE SEEMED TO BE STRONG CAUSAL RELATIONSHIP BETWEEN SEPRAFILM AND THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 28-AUG-2015: GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 16-SEP-2015 FROM PHYSICIAN (OBSTETRICIAN/GYNECOLOGIST). ADDITIONAL EVENTS OF ASCITES, VAGINAL STUMP DEHISCENCE/ ABDOMINAL WALL WOUND DEHISCENCE, WBC WERE HIGH AND PSEUDOMONAS AERUGINOSA WAS ISOLATED WITH DETAILS WERE ADDED. THE EVENT OF INCREASED C REACTIVE PROTEIN WAS UPDATED AS SYMPTOM OF PERITONITIS. THE AGE OF PATIENT WAS ADDED. ADDITIONAL CORRECTIVE TREATMENT (CONSERVATIVE THERAPY AND RELAPAROTOMY) FOR POSTOPERATIVE ILEUS WAS ADDED. OUTCOME FOR POSTOPERATIVE ILEUS AND PERITONITIS WAS UPDATED AND THEIR STOP DATE AND SEVERITY WERE ADDED. SERIOUSNESS CRITERIA AND SEVERITY FOR PERITONITIS WAS UPDATED. START DATE FOR THE EVENTS OF PERITONITIS AND POSTOPERATIVE ILEUS WAS UPDATED. REPORTING OBSTETRICIAN/GYNECOLOGISTS COMMENT (INFORMATION REGARDING ANOTHER CAUSATIVE FACTOR) WAS UPDATED. MEDICAL HISTORY INFORMATION AND LAB DETAILS WERE ADDED. CLINICAL COURSE WAS UPDATED AND TEXT AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 16-SEP-2015: THIS CASE CONCERNS A 44 YEAR OLD FEMALE PATIENT WHO UNDERWENT SURGERY AND SHEETS OF SEPRAFILM WERE APPLIED. LATER SHE DEVELOPED PERITONITIS, POST-OPERATIVE ILEUS, PAIN AND DIARRHOEA, ABDOMINAL ADHESIONS, WOUND SITE DEHISCENCE AND ASCITES WITH PSEUDOMONAS AERUGINOSA INFECTION. SINCE, A SIGNIFICANT TEMPORAL RELATIONSHIP CAN BE ESTABLISHED BETWEEN PRODUCT AND EVENT START DATE, A CAUSAL ROLE OF SEPRAFILM CANNOT BE EXCLUDED IN OCCURRENCE OF THE EVENT. HOWEVER, THE UNDERLYING CONDITION OF OVARIAN CANCER IS A CONFOUNDING FACTOR FOR THE EVENT OF PSEUDOMONAS AERUGINOSA INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559814 | SEPRAFILM | BIORESORBABLE ADHESION BARRIER | MCN | GENZYME BIOSURGERY (SEPRAFILM/PACK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| L| R |