SEPRAFILM (SEPRAFILM)
Report
- Report Number
- 1220423-2017-00001
- Event Type
- Injury
- Date Received
- April 22, 2017
- Date of Event
- February 24, 2017
- Report Date
- March 23, 2017
- 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 CASE FROM (B)(6) WAS RECEIVED ON 23-MAR-2017 FROM A SURGEON. THIS CASE CONCERNS A (B)(6) MALE WHO RECEIVED APPLICATION OF SEPRAFILM AND AFTER 7 DAYS HAD ALLERGIC REACTION/ ALLERGIC GRANULATION. THE MEDICAL HISTORY WAS SIGNIFICANT FOR CANCER OF DESCENDING COLON. THE UNDERLYING DISEASE WAS RECTAL CANCER. THE CONCURRENT CONDITIONS WERE HYPERTENSION AND HYPERURICAEMIA. NO RELEVANT PAST DRUG OR CONCOMITANT MEDICATION WAS REPORTED. ON (B)(6) 2017, THE PATIENT UNDERWENT LOW ANTERIOR RESECTION OF THE RECTUM FOR RECTAL CANCER, AND ONE SHEET OF SEPRAFILM ONCE (ROUTE, INDICATION, BATCH NUMBER AND EXPIRATION DATE: NOT REPORTED) WAS APPLIED UNDER THE INCISIONAL WOUND. ON (B)(6) 2017, 7 DAYS AFTER SEPRAFILM PLACEMENT, ALLERGIC REACTION OCCURRED AT THE SITE THAT WAS OBVIOUSLY SEEMED TO BE THE APPLICATION SITE OF SEPRAFILM. FORMATION OF GRANULATION TISSUE WAS OBSERVED AT THE APPLICATION SITE OF SEPRAFILM, AND PATHOLOGICAL EXAMINATION OF THE TISSUE SHOWED ALLERGIC GRANULATION. AS OF (B)(6) 2017, THE PATIENT HAD NOT RECOVERED FROM THE EVENT. CORRECTIVE TREATMENT: NOT REPORTED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PT NUMBER: (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE IS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY 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 PROVIDES ASSURANCE THAT ALL PRODUCT LOTS ARE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS ARE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL IS DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT IS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WILL BE REOPENED AND A LOT INVESTIGATION WILL BE PERFORMED BY SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: ALLERGIC REACTION. REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. UPON INTERNAL REVIEW ON 11-APR-2017, THE ASSOCIATED SYMPTOM OF FORMATION OF GRANULATION TISSUE WAS ADDED FOR THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18-APR-2017: GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.
THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 23- MAR-2017 FROM A SURGEON. THIS CASE CONCERNS A (B)(6) MALE WHO RECEIVED APPLICATION OF SEPRAFILM AND AFTER 7 DAYS HAD ALLERGIC REACTION/ ALLERGIC GRANULATION, ILEUS; AFTER FEW DAYS HAD REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL, INTRA-ABDOMINAL ABSCESS, PARTIAL DAMAGE OF THE SMALL INTESTINE AND THE PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES THE MEDICAL HISTORY WAS SIGNIFICANT FOR CANCER OF DESCENDING COLON. THE UNDERLYING DISEASE WAS RECTAL CANCER. THE CONCURRENT CONDITIONS WERE HYPERTENSION AND HYPERURICAEMIA. PATIENT HAD NO CONCURRENT CONDITION BEFORE SURGERY. PATIENT HAD NO DIABETES MELLITUS, ANAEMIA AND RADIOTHERAPY; ALLERGIC PREDISPOSITION WAS UNKNOWN. IT WAS REPORTED THAT PATIENT DOES SMOKING. PATIENT HAD HISTORY OF SURGERY: SURGERY FOR CANCER OF DESCENDING COLON IN 2002 AND ILEUS SURGERY IN 2009. IT WAS REPORTED THAT PATIENT PREOPERATIVE CONDITION WAS GENERALLY HEALTHY, CONCURRENT SEVERE SYSTEMIC DISEASE; AND NUTRITION STATUS WAS GOOD. CONCOMITANT MEDICATION INCLUDES CELECOXIB (CELECOX) AND REBAMIPIDE FOR PAIN CONTROL, CEFMETAZOLE AS PROPHYLAXIS. NO RELEVANT PAST DRUG WAS REPORTED. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE REPORTING HOSPITAL FOR SURGERY. ON (B)(6) 2017, THE PATIENT UNDERWENT LOW ANTERIOR RESECTION OF THE RECTUM FOR RECTAL CANCER, AND ONE SHEET OF SEPRAFILM ONCE (ROUTE, FORM, INDICATION, BATCH NUMBER AND EXPIRATION DATE: NOT REPORTED) WAS APPLIED UNDER THE INCISIONAL WOUND WHICH WAS AN ELECTIVE SURGERY. NO HYPERTHERMIC THERAPY WAS PERFORMED DURING THE SURGERY. SEPRAFILM WAS USED WITHOUT BEING APPLIED DIRECTLY TO THE ANASTOMOSIS SITE. THERE WAS NO INFECTION IN THE APPLICATION SITE. THE CONDITION OF APPLICATION WAS FAVORABLE. THERE WERE PRE-EXISTING ADHESIONS IN THE INTRAPERITONEAL AREA (GREATER OMENTUM AND ABDOMINAL WALL), FOR WHICH ADHESIOLYSIS WAS PERFORMED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION WAS PERFORMED (3 L). THE AREA FROM THE RECTUM TO THE SIGMOID COLON WAS RESECTED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE RESECTION SITES. THE RESECTION SITES WERE ANASTOMOSED WITH A MACHINE. THE OPERATIVE FIELD WAS CLEAN CONTAMINATED. THE LENGTH OF LAPAROTOMY INCISION WAS 25 CM, AND INVOLVED SATURATION OF 2 LAYERS. THE FIRST LAYER (PERITONEUM) WAS SUTURED WITH ABSORBABLE, MONO THREAD (CMONODIOX, INTERRUPTED SUTURE). THE SKIN WAS SUTURED WITH ABSORBABLE, MONO THREAD (4-0 MONODIOX) BY HANDS (INTERRUPTED SUTURE). NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. IT WAS REPORTED THAT THE OPERATIVE TIME WAS APPROXIMATELY 5 HOURS. THE VOLUME OF HAEMORRHAGE WAS 575 G AND NO BLOOD TRANSFUSION WAS PERFORMED. A DRAINAGE TUBE (M-VAC) WAS PLACED ON THE DAY (CLOSED DRAIN), AND THE DRAINAGE CONDITION IMMEDIATELY AFTER THE PLACEMENT WAS FAVORABLE. (AT THE TIME OF THE EVENT ONSET ON (B)(6) 2017, THE DRAINAGE FLUID WAS SEROUS). ON (B)(6) 2017, 7 DAYS AFTER SEPRAFILM PLACEMENT, ALLERGIC REACTION OCCURRED AT THE SITE THAT WAS OBVIOUSLY SEEMED TO BE THE APPLICATION SITE OF SEPRAFILM. FORMATION OF GRANULATION TISSUE WAS OBSERVED AT THE APPLICATION SITE OF SEPRAFILM, AND PATHOLOGICAL EXAMINATION OF THE TISSUE SHOWED ALLERGIC GRANULATION. ON THE SAME DAY, A CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED FOR DETAILED EXAMINATION OF VOMITING. IT WAS REPORTED THAT ILEUS (ALLERGIC REACTION; MODERATE) WAS NOTED. (LAPAROTOMY WAS PERFORMED ON THE DAY BECAUSE THERE WAS A POSSIBILITY OF INTERNAL HERNIA). ON THE SAME DAY, LABORATORY TESTS REGARDING INFECTION AND INFLAMMATION WERE PERFORMED: WHITE BLOOD CELLS (WBC) WAS 6800/MICROLITER; NEUTROPHILS WAS 62.3 PERCENT; EOS (EOSINOPHILS) WAS 12.9 PERCENT AND CRP (C-REACTIVE PROTEIN) WAS 2.76 MG/DL. ON AN UNKNOWN DATE IN 2017, FEW DAYS AFTER SEPRAFILM PLACEMENT, REMARKABLE INTRAPERITONEAL ADHESION, SCLEROSIS OF INTESTINAL WALL, AND GRANULOMATOUS CHANGE (REMARKABLE GRANULATION) WERE OBSERVED. THE INTESTINE WAS LUMPED TOGETHER AND ADHESIOLYSIS WAS DIFFICULT. IT WAS REPORTED THAT THE PARTIAL DAMAGE OF THE SMALL INTESTINE WAS ALSO NOTED, WHICH REQUIRED SUTURATION. THERE WERE NO FINDINGS OF INTERNAL HERNIA, AND THE PATIENT WAS CONSIDERED TO HAVE OBSTRUCTION OF INTESTINE DUE TO TISSUE CONSOLIDATION. IT WAS STATED THAT THE SEPRAFILM COULD NOT BE REMOVED AND THE EVENTS IMPROVED AFTER THIS SURGERY. AFTER THE SURGERY, THE PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES AND INTRAABDOMINAL ABSCESS. IT WAS REPORTED THAT THE ULTRASOUND GUIDED NEEDLING AND DRAINAGE, ANTIBIOTIC MEDICATION, FASTING, AND INTRAVENOUS HYPERALIMENTATION (IVH) MANAGEMENT WERE PERFORMED, AND THE CONDITIONS IMPROVED. ON (B)(6) 2017, PUS (DRAINAGE TUBE) CULTURE WAS PERFORMED AND STAPHYLOCOCCUS EPIDERMIDIS, BACILLUS, AND HAEMOPHILUS PARAINFLUENZAE WERE DETECTED. ON (B)(6) 2017, THE EVENTS RESOLVED AND PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO THE EVENT, BUT THE PATIENT WAS NOT RE-HOSPITALIZED FOR THE EVENT. CORRECTIVE TREATMENT: SURGERY FOR ILEUS AND REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL; DRAINAGE, ANTIBIOTIC MEDICATION, CEFTRIAXONE FOR INTRA-ABDOMINAL ABSCESS; SUTURATION FOR PARTIAL DAMAGE OF THE SMALL INTESTINE; NOT REPORTED FOR REST EVENTS. OUTCOME: RECOVERED FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PT NUMBER: 47231 NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE IS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY 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 PROVIDES ASSURANCE THAT ALL PRODUCT LOTS ARE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS ARE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL IS DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT IS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WILL BE REOPENED AND A LOT INVESTIGATION WILL BE PERFORMED BY SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: ALLERGIC REACTION. REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE DIAGNOSIS: ILEUS. REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. SERIOUSNESS CRITERION: HOSPITALIZATION FOR ALL EVENTS. REPORTING SURGEON'S COMMENT: IT WAS POSSIBLE THAT FOREIGN BODY REACTION TO SEPRAFILM CAUSED TISSUE CONSOLIDATION AND GRANULATION, WHICH COMPRESSED THE INTESTINE AND LEAD TO THE OBSTRUCTION. HISTOLOGICAL EXAMINATION SHOWED FOREIGN BODY GRANULOMA REACTION (FOREIGN BODY GRANULOMA AND FIBROSIS WERE NOTED; UNKNOWN. DATE) UPON INTERNAL REVIEW ON 11-APR-2017, THE ASSOCIATED SYMPTOM OF FORMATION OF GRANULATION TISSUE WAS ADDED FOR THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18-APR-2017: GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 30-MAY-2017 FROM A SURGEON. EVENTS OF REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL, INTRA-ABDOMINAL ABSCESS, PARTIAL DAMAGE OF THE SMALL INTESTINE, THE PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES AND ILEUS WERE ADDED ALONG WITH ITS DETAILS. OUTCOME WAS UPDATED FOR THE EVENT OF ALLERGIC REACTION/ ALLERGIC GRANULATION FROM NOT RECOVERED TO RECOVERED. UPDATED MEDICAL HISTORY AND THE PATIENT'S INFORMATION; ADDED THE REPORTER'S COMMENT, EXAMINATION FINDINGS, LABORATORY DATA, AND CONCOMITANT DRUGS. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 30-MAY-2017: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED SEPRAFILM SHEET AFTER THE PATIENT UNDERWENT LOW ANTERIOR RESECTION OF THE RECTUM FOR RECTAL CANCER AND LATER ON WAS DIAGNOSED WITH ILEUS, REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL, AND PARTIAL DAMAGE OF THE SMALL INTESTINE FOR WHICH SURGERY WAS DONE. AFTER SURGERY PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES AND INTRA-ABDOMINAL ABSCESS. THE CAUSALITY FOR THE OCCURRENCE OF ILEUS, REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL AND PARTIAL DAMAGE OF THE SMALL INTESTINE CANNOT BE RULED OUT. MOREOVER, REPORTING PHYSICIAN HAS ALSO ASSESSED THE EVENTS AS RELATED TO THE SEPRAFILM. HOWEVER, SURGICAL INTERVENTION IN ITSELF AND UNDERLYING CAUSE FOR SURGERY I.E. RECTAL CANCER ARE AN ALTERNATIVE RISK FOR THESE EVENTS. ALSO, FAILURE OF THE SMALL INTESTINAL SUTURES AND INTRA-ABDOMINAL ABSCESS OCCURRED AFTER A SECOND SURGERY AND HENCE CAUSAL ROLE IS UNLIKELY.
THIS UNSOLICITED CASE FROM (B)(6) WAS RECEIVED ON 23- MAR-2017 FROM A SURGEON. THIS CASE CONCERNS A (B)(6) MALE WHO RECEIVED APPLICATION OF SEPRAFILM AND AFTER 7 DAYS HAD ALLERGIC REACTION/ ALLERGIC GRANULATION, ILEUS AND HAD REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL THE MEDICAL HISTORY WAS SIGNIFICANT FOR CANCER OF DESCENDING COLON. THE UNDERLYING DISEASE WAS RECTAL CANCER. THE CONCURRENT CONDITIONS WERE HYPERTENSION AND HYPERURICAEMIA. PATIENT HAD NO CONCURRENT CONDITION BEFORE SURGERY. PATIENT HAD NO DIABETES MELLITUS, ANAEMIA AND RADIOTHERAPY; ALLERGIC PREDISPOSITION WAS UNKNOWN. IT WAS REPORTED THAT PATIENT DOES SMOKING. PATIENT HAD HISTORY OF SURGERY: SURGERY FOR CANCER OF DESCENDING COLON IN 2002 AND ILEUS SURGERY IN 2009. IT WAS REPORTED THAT PATIENT PREOPERATIVE CONDITION WAS GENERALLY HEALTHY, CONCURRENT SEVERE SYSTEMIC DISEASE; AND NUTRITION STATUS WAS GOOD. CONCOMITANT MEDICATION INCLUDES CELECOXIB (CELECOX) AND REBAMIPIDE FOR PAIN CONTROL, CEFMETAZOLE AS PROPHYLAXIS. NO RELEVANT PAST DRUG WAS REPORTED. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE REPORTING HOSPITAL FOR SURGERY. ON (B)(6) 2017, THE PATIENT UNDERWENT LOW ANTERIOR RESECTION OF THE RECTUM FOR RECTAL CANCER, AND ONE SHEET OF SEPRAFILM ONCE (ROUTE, FORM, INDICATION, BATCH NUMBER AND EXPIRATION DATE: NOT REPORTED) WAS APPLIED UNDER THE INCISIONAL WOUND WHICH WAS AN ELECTIVE SURGERY. NO HYPERTHERMIC THERAPY WAS PERFORMED DURING THE SURGERY. SEPRAFILM WAS USED WITHOUT BEING APPLIED DIRECTLY TO THE ANASTOMOSIS SITE. THERE WAS NO INFECTION IN THE APPLICATION SITE. THE CONDITION OF APPLICATION WAS FAVORABLE. THERE WERE PRE-EXISTING ADHESIONS IN THE INTRAPERITONEAL AREA (GREATER OMENTUM AND ABDOMINAL WALL), FOR WHICH ADHESIOLYSIS WAS PERFORMED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION WAS PERFORMED (3 L). THE AREA FROM THE RECTUM TO THE SIGMOID COLON WAS RESECTED. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE RESECTION SITES. THE RESECTION SITES WERE ANASTOMOSED WITH A MACHINE. THE OPERATIVE FIELD WAS CLEAN-CONTAMINATED. THE LENGTH OF LAPAROTOMY INCISION WAS 25 CM, AND INVOLVED SATURATION OF 2 LAYERS. THE FIRST LAYER (PERITONEUM) WAS SUTURED WITH ABSORBABLE, MONO THREAD (CMONODIOX, INTERRUPTED SUTURE). THE SKIN WAS SUTURED WITH ABSORBABLE, MONO THREAD (4-0 MONODIOX) BY HANDS (INTERRUPTED SUTURE). NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. IT WAS REPORTED THAT THE OPERATIVE TIME WAS APPROXIMATELY 5 HOURS. THE VOLUME OF HAEMORRHAGE WAS 575 G AND NO BLOOD TRANSFUSION WAS PERFORMED. A DRAINAGE TUBE (M-VAC) WAS PLACED ON THE DAY (CLOSED DRAIN), AND THE DRAINAGE CONDITION IMMEDIATELY AFTER THE PLACEMENT WAS FAVORABLE. (AT THE TIME OF THE EVENT ONSET ON (B)(6) 2017, THE DRAINAGE FLUID WAS SEROUS). ON (B)(6) 2017, 7 DAYS AFTER SEPRAFILM PLACEMENT, ALLERGIC REACTION OCCURRED AT THE SITE THAT WAS OBVIOUSLY SEEMED TO BE THE APPLICATION SITE OF SEPRAFILM. FORMATION OF GRANULATION TISSUE WAS OBSERVED AT THE APPLICATION SITE OF SEPRAFILM, AND PATHOLOGICAL EXAMINATION OF THE TISSUE SHOWED ALLERGIC GRANULATION. ON THE SAME DAY, A CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED FOR DETAILED EXAMINATION OF VOMITING. IT WAS REPORTED THAT ILEUS (ALLERGIC REACTION; MODERATE) WAS NOTED. (LAPAROTOMY WAS PERFORMED ON THE DAY BECAUSE THERE WAS A POSSIBILITY OF INTERNAL HERNIA). ON THE SAME DAY, PATIENT HAD REMARKABLE INTRAPERITONEAL ADHESION / SCLEROSIS OF INTESTINAL WALL (SEVERITY, MODERATE) WAS NOTED. ON THE SAME DAY, LABORATORY TESTS REGARDING INFECTION AND INFLAMMATION WERE PERFORMED: WHITE BLOOD CELLS (WBC) WAS 6800/MICROLITER; NEUTROPHILS WAS 62.3 PERCENT; EOS (EOSINOPHILS) WAS 12.9 PERCENT AND CRP (C-REACTIVE PROTEIN) WAS 2.76 MG/DL. THE INTESTINE WAS LUMPED TOGETHER AND ADHESIOLYSIS WAS DIFFICULT. IT WAS REPORTED THAT THE PARTIAL DAMAGE OF THE SMALL INTESTINE WAS ALSO NOTED, WHICH REQUIRED SUTURATION. THERE WERE NO FINDINGS OF INTERNAL HERNIA, AND THE PATIENT WAS CONSIDERED TO HAVE OBSTRUCTION OF INTESTINE DUE TO TISSUE CONSOLIDATION. IT WAS STATED THAT THE SEPRAFILM COULD NOT BE REMOVED AND THE EVENTS IMPROVED AFTER THIS SURGERY. AFTER THE SURGERY, THE PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES AND INTRA-ABDOMINAL ABSCESS. IT WAS REPORTED THAT THE ULTRASOUND GUIDED NEEDLING AND DRAINAGE, ANTIBIOTIC MEDICATION, FASTING, AND INTRAVENOUS HYPERALIMENTATION (IVH) MANAGEMENT WERE PERFORMED, AND THE CONDITIONS IMPROVED. ON (B)(6) 2017, PUS (DRAINAGE TUBE) CULTURE WAS PERFORMED AND STAPHYLOCOCCUS EPIDERMIDIS, BACILLUS, AND HAEMOPHILUS PARAINFLUENZAE WERE DETECTED. ON (B)(6) 2017, THE EVENTS RESOLVED AND PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO THE EVENT, BUT THE PATIENT WAS NOT RE-HOSPITALIZED FOR THE EVENT. CORRECTIVE TREATMENT: SURGERY FOR ILEUS AND REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL; NOT REPORTED FOR ALLERGIC REACTION/ ALLERGIC GRANULATION. OUTCOME: RECOVERED FOR ALL THE EVENTS. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE IS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY 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 PROVIDES ASSURANCE THAT ALL PRODUCT LOTS ARE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS ARE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL IS DISCUSSED DURING THESE TRENDING MEETINGS AND ESCALATED TO THE SAFETY GOVERNANCE FOR ADJUDICATION. IF A LOT NUMBER FOR THIS EVENT IS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WILL BE REOPENED AND A LOT INVESTIGATION WILL BE PERFORMED BY SANOFI-GENZYME BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: ALLERGIC REACTION. REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. DIAGNOSIS: ILEUS. REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. DIAGNOSIS: REMARKABLE INTRAPERITONEAL ADHESION / SCLEROSIS OF INTESTINAL WALL REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. REPORTING SURGEON'S COMMENT: IT WAS POSSIBLE THAT FOREIGN BODY REACTION TO SEPRAFILM CAUSED TISSUE CONSOLIDATION AND GRANULATION, WHICH COMPRESSED THE INTESTINE AND LEAD TO THE OBSTRUCTION. HISTOLOGICAL EXAMINATION SHOWED FOREIGN BODY GRANULOMA REACTION (FOREIGN BODY GRANULOMA AND FIBROSIS WERE NOTED; UNKNOWN DATE) UPON INTERNAL REVIEW ON 11-APR-2017, THE ASSOCIATED SYMPTOM OF FORMATION OF GRANULATION TISSUE WAS ADDED FOR THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 18-APR-2017: GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 30-MAY-2017 FROM A SURGEON. EVENTS OF REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL, INTRA-ABDOMINAL ABSCESS, PARTIAL DAMAGE OF THE SMALL INTESTINE, THE PATIENT WAS COMPLICATED WITH FAILURE OF THE SMALL INTESTINAL SUTURES AND ILEUS WERE ADDED ALONG WITH ITS DETAILS. OUTCOME WAS UPDATED FOR THE EVENT OF ALLERGIC REACTION/ ALLERGIC GRANULATION FROM NOT RECOVERED TO RECOVERED. UPDATED MEDICAL HISTORY AND THE PATIENT'S INFORMATION; ADDED THE REPORTER'S COMMENT, EXAMINATION FINDINGS, LABORATORY DATA, AND CONCOMITANT DRUGS. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JUN-2017 FROM A SURGEON. IT WAS REPORTED THAT "PARTIAL DAMAGE OF THE SMALL INTESTINE", "FAILURE OF THE SMALL INTESTINAL SUTURES", AND "INTRA-ABDOMINAL ABSCESS" WERE NOT ADVERSE REACTIONS TO THE SUSPECT DRUG AND WERE DELETED FROM THE CASE. EVENT START DATE WAS UPDATED FOR THE EVENT OF REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT FOR FOLLOW UP DATED 14-JUN-2017: THIS CASE CONCERNS A MALE PATIENT WHO RECEIVED SEPRAFILM SHEET AFTER THE PATIENT UNDERWENT LOW ANTERIOR RESECTION OF THE RECTUM FOR RECTAL CANCER AND LATER ON WAS DIAGNOSED WITH ILEUS, REMARKABLE INTRAPERITONEAL ADHESION/SCLEROSIS OF INTESTINAL WALL. THE CAUSAL ROLE OF SUSPECT PRODUCT IN OCCURRENCE OF EVENTS CANNOT BE RULED OUT ON THE BASIS OF TEMPORAL RELATIONSHIP. MOREOVER, REPORTING PHYSICIAN HAS ALSO ASSESSED THE EVENTS AS RELATED TO THE SEPRAFILM. HOWEVER, SURGICAL INTERVENTION IN ITSELF AND UNDERLYING CAUSE FOR SURGERY I.E. RECTAL CANCER ARE AN ALTERNATIVE RISK FOR THESE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295584 | SEPRAFILM (SEPRAFILM) | BIORESORBABLE ADHESION BARRIER | MCN | GENZYME BIOSURGERY (SEPRAFILM/PACK) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization |