SEPRAFILM (SEPRAFILM)
Report
- Report Number
- 1220423-2015-85719
- Event Type
- Injury
- Date Received
- November 26, 2015
- Date of Event
- October 23, 2015
- Report Date
- November 19, 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 19-NOV-2015 FROM A MEDICAL DOCTOR (PEDIATRIC SURGEON). THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AND LATER DEVELOPED ADHESIVE INTESTINAL OBSTRUCTION. THE PATIENT'S UNDERLYING DISEASE INCLUDED INTESTINAL OBSTRUCTION. THE PATIENT'S HISTORICAL CONDITION INCLUDED POSTOPERATIVE NEONATAL NECROTIZING ENTEROCOLITIS. NO PAST DRUGS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2015, RELEASE OF INTESTINAL OBSTRUCTION (INTESTINAL RESECTION AND ANASTOMOSIS) WAS PERFORMED AND 1 SHEET OF SEPRAFILM WAS APPLIED, ONCE (FORMULATION, ROUTE, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) DIRECTLY UNDER THE ABDOMINAL MIDLINE INCISIONAL WOUND. ON (B)(6) 2015, 15 DAYS AFTER RECEIVING TREATMENT WITH SEPRAFILM, ADHESIVE INTESTINAL OBSTRUCTION (SEVERE) DEVELOPED ALL OVER THE ABDOMEN INCLUDING THE APPLICATION SITE OF SEPRAFILM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REOPERATION FOR THE EVENT. AS OF (B)(6) 2015, THE PATIENT WAS RECOVERING FROM THE EVENT. CORRECTIVE TREATMENT: REOPERATION. OUTCOME: RECOVERING/RESOLVING. ADHESIVE INTESTINAL OBSTRUCTION (INTESTINAL OBSTRUCTION). REPORTING PEDIATRIC SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). REPORTING PEDIATRIC SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. REPORTING PEDIATRIC SURGEON'S COMMENT: OTHER POSSIBLE CAUSATIVE FACTORS FOR THE EVENT WERE UNKNOWN. SERIOUSNESS CRITERIA: HOSPITALISATION. (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE SANOFI GENZYME BIOSURGERY QUALITY ASSURANCE WAS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY SANOFI GENZYME ARE 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 SANOFI GENZYME BIOSURGERY QUALITY ASSURANCE AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2015. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 23-DEC-2015: THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE THE COMPLETE CASES ASSESSMENT. SANOFI COMPANY COMMENT DATED 23-NOV-2015: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AND EXPERIENCED ADHESIVE INTESTINAL OBSTRUCTION. AS PER THE INFORMATION, THE CAUSAL ROLE OF PRODUCT WITH THE OCCURRENCE OF EVENT CANNOT BE DENIED. HOWEVER, LACK OF INFORMATION REGARDING THE PATIENT'S UNDERLYING CONDITION, CONCOMITANT MEDICATIONS AND RISK FACTORS PRECLUDES THE COMPLETE MEDICAL CASE ASSESSMENT.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A MEDICAL DOCTOR (PEDIATRIC SURGEON). THIS CASE CONCERNS A (B)(6) MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AND LATER DEVELOPED INTESTINAL OBSTRUCTION AND ADHESION. THE PATIENT'S UNDERLYING DISEASE INCLUDED INTESTINAL OBSTRUCTION. THE PATIENT'S HISTORICAL CONDITION INCLUDED NEONATAL NECROTISING ENTEROCOLITIS, INTESTINAL RESECTION AND ANASTOMOSIS. THE CONCURRENT CONDITIONS INCLUDED SYSTEMIC DISEASE. NO PAST DRUGS OR CONCOMITANT MEDICATIONS WERE REPORTED. THE PATIENT'S NUTRITION STATUS WAS POOR AND HAD NO HISTORY OF SMOKING. ON AN UNKNOWN DATE IN (B)(6) 2015, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGERY. ON (B)(6) 2015, HE UNDERWENT INTESTINAL RESECTION WITH INTESTINAL ANASTOMOSIS, WHICH WAS NOT AN ELECTIVE SURGERY. IT WAS REPORTED THAT NO HYPERTHERMIC THERAPY WAS PERFORMED DURING THE SURGERY. ON (B)(6) 2015, RELEASE OF INTESTINAL OBSTRUCTION (INTESTINAL RESECTION AND ANASTOMOSIS) WAS PERFORMED AND 1 SHEET OF SEPRAFILM WAS APPLIED, ONCE (FORMULATION, ROUTE, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) DIRECTLY UNDER THE ABDOMINAL MIDLINE INCISIONAL WOUND WITHOUT BEING APPLIED DIRECTLY TO THE ANASTOMOSIS SITE. IT WAS REPORTED THAT THERE WAS NO INFECTION IN THE APPLICATION SITE AND THE CONDITION OF APPLICATION WAS FAVORABLE. ALSO REPORTED THAT THE OPERATING SURGEON HAD A LOT OF EXPERIENCE IN USING SEPRAFILM. NO PRE-EXISTING ADHESION WAS OBSERVED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION WAS PERFORMED (1 L). THE PATIENT'S ILEUM WAS RESECTED AND THERE WAS PRE-EXISTING NON-PURULENT INFLAMMATION, BUT NO PRE-EXISTING INFECTION WAS OBSERVED IN THE RESECTION SITES. IT WAS REPORTED THAT THE RESECTION SITES WERE ANASTOMOSED WITH HANDS (INTERRUPTED ANASTOMOSIS). THE INNER AND OUTER LAYERS WERE SUTURED WITH PDS (ABSORBABLE MONO THREAD). THE LENGTH OF LAPAROTOMY INCISION WAS 8 CM, AND INVOLVED SATURATION OF 2 LAYERS. THE FIRST LAYER (PERITONEUM) WAS SUTURED WITH ABSORBABLE MONO THREAD (INTERRUPTED SUTURE).THE SKIN WAS STAPLED WITH HANDS USING ABSORBABLE MONO THREAD. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. THE OPERATIVE TIME WAS APPROXIMATELY 2 HOURS. THE VOLUME OF HAEMORRHAGE WAS 5 G AND NO BLOOD TRANSFUSION WAS PERFORMED. NO OTHER MEDICAL DEVICE WAS USED CONCOMITANTLY AFTER THE SURGERY. ON (B)(6) 2015, 15 DAYS AFTER RECEIVING TREATMENT WITH SEPRAFILM, SEVERE INTESTINAL OBSTRUCTION AND ADHESION DEVELOPED (CONFIRMED ON X-RAY). IT WAS REPORTED THAT THE PATIENT UNDERWENT RE-LAPAROTOMY FOR THE EVENT. IT WAS REPORTED THAT SEVERE AND FIRM ADHESION WAS OBSERVED AND HIS INTRAPERITONEAL ORGANS WERE LUMPED TOGETHER. INTESTINAL RESECTION WAS PERFORMED, AND THE EVENTS REMARKABLY IMPROVED AFTER THIS SURGERY. REPORTEDLY, THE PATIENT WAS NOT RE-HOSPITALIZED FOR THE EVENT, BUT THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO THE EVENTS. IT WAS REPORTED THAT THE PATIENT WAS RECOVERING FROM THE EVENTS AFTER THE RE-LAPAROTOMY. CORRECTIVE TREATMENT: RELAPAROTOMY WITH INTESTINAL RESECTION FOR BOTH THE EVENTS. OUTCOME: RECOVERING/RESOLVING FOR BOTH THE EVENTS INTESTINAL OBSTRUCTION (INTESTINAL OBSTRUCTION). REPORTING PEDIATRIC SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (MEDICALLY SIGNIFICANT). DIAGNOSIS: ADHESION (ADHESION). REPORTING PEDIATRIC SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (MEDICALLY SIGNIFICANT). REPORTING PEDIATRIC SURGEON'S COMMENT: ANOTHER POSSIBLE CAUSATIVE FACTOR FOR THE EVENTS WAS SURGICAL INVASION. (B)(4) NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE SANOFI GENZYME BIOSURGERY QUALITY ASSURANCE WAS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY SANOFI GENZYME ARE 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 SANOFI GENZYME BIOSURGERY QUALITY ASSURANCE AT THAT TIME. SERIOUSNESS CRITERIA: MEDICALLY SIGNIFICANT FOR BOTH THE EVENTS ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2015. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 21-JAN-2016 FROM THE MEDICAL DOCTOR (PEDIATRIC SURGEON). THE EVENT TERM WAS UPDATED FROM "ADHESIVE INTESTINAL OBSTRUCTION" TO "INTESTINAL OBSTRUCTION" . THE ADDITIONAL EVENT OF ADHESION WAS ADDED WITH DETAILS. THE SERIOUSNESS ASSESSMENT FOR THE EVENT OF INTESTINAL OBSTRUCTION WAS UPDATED FROM "SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION)" TO "SERIOUS (MEDICALLY SIGNIFICANT)". THE MEDICAL HISTORY OF NECROTISING ENTEROCOLITIS, INTESTINAL RESECTION AND ANASTOMOSIS WERE ADDED. THE CONCURRENT CONDITION OF SYSTEMIC DISEASE (CONCURRENT SEVERE) WAS ADDED. CLINICAL COURSE UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 21-JAN-2016: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AFTER INTESTINAL RESECTION SURGERY AND LATER DEVELOPED INTESTINAL OBSTRUCTION AND ADHESION. BASED UPON THE POSITIVE TEMPORAL RELATIONSHIP, THE CAUSAL ROLE OF PRODUCT CANNOT BE DENIED IN THE OCCURRENCE OF EVENTS. HOWEVER, ANOTHER POSSIBLE CAUSATIVE FACTOR COULD BE THE SURGICAL INVASION ITSELF WHICH ACTS AS A CONFOUNDING FACTOR, HENCE NOT ALLOWING A COMPREHENSIVE CASE ASSESSMENT.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 FROM A MEDICAL DOCTOR (PEDIATRIC SURGEON). THIS CASE CONCERNS A (B)(6) YEAR OLD MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AND LATER DEVELOPED ADHESIVE INTESTINAL OBSTRUCTION. THE PATIENT'S UNDERLYING DISEASE INCLUDED INTESTINAL OBSTRUCTION. THE PATIENT'S HISTORICAL CONDITION INCLUDED POSTOPERATIVE NEONATAL NECROTISING ENTEROCOLITIS. NO PAST DRUGS OR CONCOMITANT MEDICATIONS WERE REPORTED. ON (B)(6) 2015, RELEASE OF INTESTINAL OBSTRUCTION (INTESTINAL RESECTION AND ANASTOMOSIS) WAS PERFORMED AND 1 SHEET OF SEPRAFILM WAS APPLIED, ONCE (FORMULATION, ROUTE, INDICATION, BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) DIRECTLY UNDER THE ABDOMINAL MIDLINE INCISIONAL WOUND. ON (B)(6) 2015, 15 DAYS AFTER RECEIVING TREATMENT WITH SEPRAFILM, ADHESIVE INTESTINAL OBSTRUCTION (SEVERE) DEVELOPED ALL OVER THE ABDOMEN INCLUDING THE APPLICATION SITE OF SEPRAFILM. IT WAS REPORTED THAT THE PATIENT UNDERWENT REOPERATION FOR THE EVENT. AS OF (B)(6) 2015, THE PATIENT WAS RECOVERING FROM THE EVENT. CORRECTIVE TREATMENT: REOPERATION. OUTCOME: RECOVERING/RESOLVING. ADHESIVE INTESTINAL OBSTRUCTION (INTESTINAL OBSTRUCTION). REPORTING PEDIATRIC SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). REPORTING PEDIATRIC SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. REPORTING PEDIATRIC SURGEON'S COMMENT: OTHER POSSIBLE CAUSATIVE FACTORS FOR THE EVENT WERE UNKNOWN. SERIOUSNESS CRITERIA: HOSPITALISATION. A PHARMACEUTICAL COMPLAINT WAS INITIATED AND RESULTS WERE PENDING FOR THE SAME. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 23-NOV-2015: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED TREATMENT WITH SEPRAFILM AND EXPERIENCED ADHESIVE INTESTINAL OBSTRUCTION. AS PER THE INFORMATION, THE CAUSAL ROLE OF PRODUCT WITH THE OCCURRENCE OF EVENT CANNOT BE DENIED. HOWEVER, LACK OF INFORMATION REGARDING THE PATIENT'S UNDERLYING CONDITION, CONCOMITANT MEDICATIONS AND RISK FACTORS PRECLUDES THE COMPLETE MEDICAL CASE ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782337 | SEPRAFILM (SEPRAFILM) | BIORESORBABLE ADHESION BARRIER | MCN | GENZYME BIOSURGERY (SEPRAFILM/PACK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Hospitalization| O |