SEPRAFILM (SEPRAFILM)
Report
- Report Number
- 1220423-2015-85109
- Event Type
- Injury
- Date Received
- June 17, 2015
- Date of Event
- June 6, 2011
- Report Date
- June 11, 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
A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE 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 PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/(B)(4) AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WAS 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 A LOT INVESTIGATION WOULD BE PERFORMED BY GENZYME-(B)(4) QUALITY ASSURANCE AT THAT TIME. REPORTER CAUSALITY: SEPRAFILM AS POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE FOLLOW UP WAS RECEIVED ON JULY 10, 2015. NO NEW INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 10, 2015. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 11-JUN-2015 VIA CONFERENCE ABSTRACT: NISHITAI R, MANAKA D, HAMASU S, KONISHI S. FIVE CASES OF FASCIAL DEHISCENCE WITH USE OF SEPRAFILM NOTED EARLY AFTER HEPATO-BILIARY-PANCREATIC SURGERY "SPRAFILM" AS A POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE. THE 27TH MEETING OF JAPANESE SOCIETY OF HEPATO-BILIARY-PANCREATIC SURGERY; 2015 JUN 11-13; TOKYO, JAPAN. FROM THIS ARTICLE, THE OTHER CASES CREATED WERE: (B)(6) (CLUSTER). THIS CASE INVOLVES A (B)(6) MALE PATIENT WHO EXPERIENCED FASCIAL DEHISCENCE AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG WAS PROVIDED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OBESITY, ASYMPTOMATIC OLD CEREBRAL INFARCTION, HYPOALBUMINAEMIA WITH ALBUMIN OF 3.0 G/DL, HYPERTENSION AND ASYMPTOMATIC CEREBRAL INFARCTION (IN 2000). THE CONCURRENT CONDITION BEFORE SURGERY WAS CHOLECYSTITIS ACUTE (IN (B)(6) 2011). THE UNDERLYING DISEASE (SURGERY INDICATION) WAS WIDE LAYER SPREADING TYPE GALLBLADDER AND BILE DUCT CANCER. THE PATIENT HAD NO DIABETES MELLITUS, ALLERGY, ANAEMIA OR RADIOTHERAPY. THE PATIENT HAD NO HISTORY OF SURGERY OR SMOKING. THE NUTRITION STATUS OF THE PATIENT WAS GOOD. THE CONCOMITANT MEDICATIONS WERE CEFAZOLIN AS WOUND INFECTION PROPHYLAXIS, VALSARTAN (DIOVAN) AND ADENOSINE (TRICOR). ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE REPORTING HOSPITAL FOR SURGERY. THE PATIENT'S PREOPERATIVE CONDITION WAS GENERALLY HEALTHY. ON AN UNKNOWN DATE, AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) TUBE WAS PLACED BEFORE SURGERY FOR SUPERFICIAL-SPREADING-TYPE CYSTIC DUCT CANCER. ON (B)(6) 2011, EXTRAHEPATIC BILE DUCT RESECTION WITH RECONSTRUCTION AS AN ELECTIVE SURGERY (DEFINITIVE OPERATION FOR THE UNDERLYING DISEASE) WAS PERFORMED IN UPPER ABDOMINAL MEDIAN INCISION APPROACH AND ONE SHEET OF SEPRAFILM WAS APPLIED DIRECTLY TO THE ANASTOMOSIS SITE UNDER THE WOUND ONCE (FORMULATION, ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE: UNKNOWN) FOR CYSTIC DUCT CANCER. IT WAS REPORTED THAT THERE WAS NO INFECTION IN THE APPLICATION SITE. THE CONDITION OF APPLICATION WAS FAVORABLE. THE OPERATING SURGEON WAS EXPERIENCED (MORE THAN 10 CASES BEFORE THIS CASE) IN USING SEPRAFILM. NO PRE-EXISTING ADHESION WAS OBSERVED. THERE WAS PRE-EXISTING NON-PURULENT INFLAMMATION, BUT NO PREEXISTING INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION WAS PERFORMED (5 L). HIS EXTRAHEPATIC BILE DUCT WAS RESECTED. THERE WAS PRE-EXISTING NON-PURULENT INFLAMMATION (GALLBLADDER INFECTION), BUT NO PRE-EXISTING INFECTION WAS OBSERVED IN THE RESECTION SITE. THE RESECTION SITE WAS ANASTOMOSED WITH HAND SUTURE (INTERRUPTED ANASTOMOSIS). SUTURE USED FOR THE INNER LAYER (ANASTOMOSIS OF ALL LAYERS OF THE BILE DUCT AND JEJUNUM), OUTER LAYER (LAYER-TO-LAYER ANASTOMOSIS OF THE JEJUNUM), AND LIGATION WAS ABSORBABLE, SYNTHETIC MULTI THREAD (VICRYL). OPERATIVE FIELD WAS CLEAN-CONTAMINATED (INVOLVED INCISION OF GASTROINTESTINAL TRACT). THE LENGTH OF LAPAROTOMY INCISION WAS 25 CM, AND INVOLVED SATURATION OF 3 LAYERS. THE FIRST LAYER (PERITONEUM) WAS CONTINUOUSLY SUTURED WITH ABSORBABLE, SYNTHETIC, MULTI THREAD (VICRYL). THE SKIN WAS STAPLED WITH SKIN STAPLER. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. THE OPERATIVE TIME WAS APPROXIMATELY 8 HOURS. THE VOLUME OF HAEMORRHAGE WAS 1075 G AND NO BLOOD TRANSFUSION WAS PERFORMED. IVH CATHETER WAS PLACED ON THE DAY. THE DRAINAGE CONDITION IMMEDIATELY AFTER THE PLACEMENT WAS FAVORABLE. (AT THE TIME OF THE EVENT ONSET ON (B)(6) 2011, THE DRAINAGE TUBE HAD ALREADY BEEN REMOVED). ON (B)(6) 2011, THE COURSE WAS FAVORABLE AND THE PATIENT RESUMED EATING. THE AMOUNT OF DRAINAGE FLUID WAS SMALL (20 ML/DAY). BLOOD TRANSFUSION WAS ADMINISTERED. ON AN UNKNOWN DATE, ON POSTOPERATIVE DAY (B)(6) 2015, THE AMOUNT OF FLUID THROUGH THE DRAIN RAPIDLY INCREASED TO 260 ML AND 58 ML ON (B)(6) 2015. ON (B)(6) 2015, THE DRAINAGE TUBE WAS REMOVED. ON (B)(6) 2011, EFFLUX OF ASCITES FROM THE SURGICAL WOUND WAS NOTED. ON (B)(6) 2011 AN UNKNOWN DATE, ON POSTOPERATIVE DAY 10, COMPLETE DEHISCENCE WAS OBSERVED IMMEDIATELY AFTER THE EFFLUX OF ASCITES FROM THE SURGICAL WOUND WAS NOTED AND THE ONSET OF THE PATIENT DEVELOPED MODERATE FASCIAL DEHISCENCE WAS CONFIRMED BY ABDOMINAL FINDINGS. AS THE SMALL INTESTINE WAS HERNIATED, THE PATIENT UNDERWENT RE-LAPAROTOMY IN EMERGENCY WITH GENERAL ANAESTHESIA ON THE DAY, AND THE FASCIA WAS RE-SUTURED. SEPRAFILM WAS COMPLETELY ABSORBED INTO THE BODY AND WAS NOT REMOVED. THE EVENT REMARKABLY IMPROVED AFTER THIS SURGERY. THE SAME DAY, THE WHITE BLOOD CELL (WBC) COUNT WAS 7010/MCL AND C-REACTIVE PROTEIN (CRP) WAS 1.8 MG/DL (NORMAL RANGE NOT PROVIDED FOR BOTH). ON (B)(6) 2011, THE PATIENT HAD PARALYTIC ILEUS, AND ILEUS TUBE WAS PLACED. ON (B)(6) 2011, ILEUS IMPROVED, AND THE ILEUS TUBE WAS REMOVED. ON (B)(6) 2011, THE PATIENT RESUMED EATING. ON (B)(6) 2011, THE SUBCUTANEOUS DRAINAGE TUBE WAS REMOVED FROM THE WOUND. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERED FROM THE FASCIAL DEHISCENCE WITH A SEQUELA OF VENTRAL HERNIA. IT WAS REPORTED THAT THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT REHOSPITALIZED FOR TREATMENT. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED WITH SEQUELAE. A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE 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 PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WAS 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 A LOT INVESTIGATION WOULD BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: FASCIAL DEHISCENCE (ABDOMINAL WOUND DEHISCENCE). REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. REPORTING SURGEON'S COMMENT: THE ALTERNATIVE EXPLANATION FOR THE EVENT WAS OBESITY. THE PATIENT HAD COMPLETE FASCIAL DEHISCENCE WITHOUT WOUND INFECTION IN EARLY PHASE AFTER SURGERY (ON POSTOPERATIVE DAY 10), AND IT WAS CONSIDERED THAT THERE WAS A SIGNIFICANT DISTURBANCE IN FASCIAL HEALING. OBESITY, A LARGE AMOUNT OF ASCITES, AND UNDERNUTRITION COULD HAVE INVOLVED IN THE EVENT, BUT THE POSSIBILITY OF DYSGRAPHIA DUE TO SEPRAFILM ALSO COULD NOT BE EXCLUDED. REPORTER CAUSALITY: SEPRAFILM AS POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE. FOLLOW UP WAS RECEIVED ON 10-JUL-2015. NO NEW INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON 10-JUL-2015. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2016 FROM THE SURGEON. THE MEDICAL HISTORY, CONCURRENT CONDITION AND CONCOMITANT MEDICATIONS WERE ADDED. THE VERBATIM FOR THE EVENT WAS UPDATED FROM EARLY POSTOPERATIVE FASCIAL DEHISCENCE TO FASCIAL DEHISCENCE. THE DOSAGE AND START DATE OF THE SUSPECT PRODUCT WERE ADDED. THE EVENT START DATE WAS ADDED. THE DETAILED DESCRIPTION OF THE EVENT, EXAMINATION FINDINGS AND LABORATORY DATA WERE ADDED. THE OUTCOME WAS UPDATED FROM UNKNOWN TO RECOVERED WITH SEQUELA (VENTRAL HERNIA). THE SERIOUSNESS CRITERION WAS UPDATED FROM IMPORTANT MEDICAL EVENT TO INPATIENT/PROLONGED HOSPITALIZATION. THE REPORTING SURGEON'S COMMENT WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 29-MAR-2016 FROM THE SURGEON. EVENT STOP DATE WAS UPDATED FROM 24-DEC-2015 TO 26-JUN-2011. CLINICAL COURSE WAS UPDATED AND TEXT WAS AMENDED ACCORDINGLY. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED 29-MAR-2016: THIS CASE CONCERNS A PATIENT WHO RECEIVED SEPRAFILM TO PREVENT POSTOPERATIVE ADHESION AFTER EXTRA-HEPATIC BILE DUCT RESECTION WITH RECONSTRUCTION AND LATER ON DEVELOPED ABDOMINAL WOUND DEHISCENCE. BASED UPON THE AVAILABLE INFORMATION A POSITIVE TEMPORAL RELATIONSHIP CAN BE ESTABLISHED WHICH INDICATES A POSSIBLE CAUSAL ROLE IN THE OCCURRENCE OF THE EVENT AND THE APPLICATION OF THE PRODUCT. HOWEVER, THE PATIENT HAD WIDE LAYER SPREADING TYPE GALLBLADDER AND BILE DUCT CANCER, AND HAD RISK FACTORS INCLUDING ACUTE CHOLECYSTITIS, AND OBESITY. HENCE, A COMPREHENSIVE CASE ASSESSMENT CANNOT BE CONCLUDED.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON 11-JUN-2015 VIA CONFERENCE ABSTRACT: (B)(4). FIVE CASES OF FASCIAL DEHISCENCE WITH USE OF SEPRAFILM NOTED EARLY AFTER HEPATO-BILIARY-PANCREATIC SURGERY "SEPRAFILM" AS A POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE. (B)(4). FROM THIS ARTICLE, THE OTHER CASES CREATED WERE: (B)(6) (CLUSTER). THIS CASE INVOLVES A (B)(6) MALE PATIENT WHO EXPERIENCED FASCIAL DEHISCENCE AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG WAS PROVIDED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OBESITY, ASYMPTOMATIC OLD CEREBRAL INFARCTION, HYPOALBUMINAEMIA WITH ALBUMIN OF 3.0 G/DL, HYPERTENSION AND ASYMPTOMATIC CEREBRAL INFARCTION (IN 2000). THE CONCURRENT CONDITION BEFORE SURGERY WAS CHOLECYSTITIS ACUTE (IN (B)(6) 2011). THE UNDERLYING DISEASE (SURGERY INDICATION) WAS WIDE LAYER SPREADING TYPE GALLBLADDER AND BILE DUCT CANCER. THE PATIENT HAD NO DIABETES MELLITUS, ALLERGY, ANAEMIA OR RADIOTHERAPY. THE PATIENT HAD NO HISTORY OF SURGERY OR SMOKING. THE NUTRITION STATUS OF THE PATIENT WAS GOOD. THE CONCOMITANT MEDICATIONS WERE CEFAZOLIN AS WOUND INFECTION PROPHYLAXIS, VALSARTAN (DIOVAN) AND ADENOSINE (TRICOR). ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE REPORTING HOSPITAL FOR SURGERY. THE PATIENT'S PREOPERATIVE CONDITION WAS GENERALLY HEALTHY. ON AN UNKNOWN DATE, AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) TUBE WAS PLACED BEFORE SURGERY FOR SUPERFICIAL-SPREADING-TYPE CYSTIC DUCT CANCER. ON (B)(6) 2011, EXTRAHEPATIC BILE DUCT RESECTION WITH RECONSTRUCTION AS AN ELECTIVE SURGERY (DEFINITIVE OPERATION FOR THE UNDERLYING DISEASE) WAS PERFORMED IN UPPER ABDOMINAL MEDIAN INCISION APPROACH AND ONE SHEET OF SEPRAFILM WAS APPLIED DIRECTLY TO THE ANASTOMOSIS SITE UNDER THE WOUND ONCE (FORMULATION, ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE: UNKNOWN) FOR CYSTIC DUCT CANCER. IT WAS REPORTED THAT THERE WAS NO INFECTION IN THE APPLICATION SITE. THE CONDITION OF APPLICATION WAS FAVORABLE. THE OPERATING SURGEON WAS EXPERIENCED (MORE THAN 10 CASES BEFORE THIS CASE) IN USING SEPRAFILM. NO PRE-EXISTING ADHESION WAS OBSERVED. THERE WAS PRE-EXISTING NON-PURULENT INFLAMMATION, BUT NO PREEXISTING INFECTION WAS OBSERVED IN THE PERITONEAL CAVITY. INTRAPERITONEAL IRRIGATION WAS PERFORMED (5 L). HIS EXTRAHEPATIC BILE DUCT WAS RESECTED. THERE WAS PRE-EXISTING NON-PURULENT INFLAMMATION (GALLBLADDER INFECTION), BUT NO PRE-EXISTING INFECTION WAS OBSERVED IN THE RESECTION SITE. THE RESECTION SITE WAS ANASTOMOSED WITH HAND SUTURE (INTERRUPTED ANASTOMOSIS). SUTURE USED FOR THE INNER LAYER (ANASTOMOSIS OF ALL LAYERS OF THE BILE DUCT AND JEJUNUM), OUTER LAYER (LAYER-TO-LAYER ANASTOMOSIS OF THE JEJUNUM), AND LIGATION WAS ABSORBABLE, SYNTHETIC MULTI THREAD (VICRYL). OPERATIVE FIELD WAS CLEAN-CONTAMINATED (INVOLVED INCISION OF GASTROINTESTINAL TRACT). THE LENGTH OF LAPAROTOMY INCISION WAS 25 CM, AND INVOLVED SATURATION OF 3 LAYERS. THE FIRST LAYER (PERITONEUM) WAS CONTINUOUSLY SUTURED WITH ABSORBABLE, SYNTHETIC, MULTI THREAD (VICRYL). THE SKIN WAS STAPLED WITH SKIN STAPLER. NO PRE-EXISTING NON-PURULENT INFLAMMATION OR INFECTION WAS OBSERVED IN THE LAPAROTOMY INCISION SITE. THE OPERATIVE TIME WAS APPROXIMATELY 8 HOURS. THE VOLUME OF HAEMORRHAGE WAS 1075 G AND NO BLOOD TRANSFUSION WAS PERFORMED. IVH CATHETER WAS PLACED ON THE DAY. THE DRAINAGE CONDITION IMMEDIATELY AFTER THE PLACEMENT WAS FAVORABLE. (AT THE TIME OF THE EVENT ONSET ON (B)(6) 2011, THE DRAINAGE TUBE HAD ALREADY BEEN REMOVED). ON (B)(6) 2011, THE COURSE WAS FAVORABLE AND THE PATIENT RESUMED EATING. THE AMOUNT OF DRAINAGE FLUID WAS SMALL (20 ML/DAY).BLOOD TRANSFUSION WAS ADMINISTERED. ON AN UNKNOWN DATE, ON POSTOPERATIVE DAY (B)(6) 2015, THE AMOUNT OF FLUID THROUGH THE DRAIN RAPIDLY INCREASED TO 260 ML AND 58 ML ON (B)(6) 2015. ON (B)(6) 2015, THE DRAINAGE TUBE WAS REMOVED. ON (B)(6) 2011, EFFLUX OF ASCITES FROM THE SURGICAL WOUND WAS NOTED. ON (B)(6) 2011, AN UNKNOWN DATE, ON POSTOPERATIVE DAY 10, COMPLETE DEHISCENCE WAS OBSERVED IMMEDIATELY AFTER THE EFFLUX OF ASCITES FROM THE SURGICAL WOUND WAS NOTED AND THE ONSET OF THE PATIENT DEVELOPED MODERATE FASCIAL DEHISCENCE WAS CONFIRMED BY ABDOMINAL FINDINGS. AS THE SMALL INTESTINE WAS HERNIATED, THE PATIENT UNDERWENT RE-LAPAROTOMY IN EMERGENCY WITH GENERAL ANAESTHESIA ON THE DAY, AND THE FASCIA WAS RE-SUTURED. SEPRAFILM WAS COMPLETELY ABSORBED INTO THE BODY AND WAS NOT REMOVED. THE EVENT REMARKABLY IMPROVED AFTER THIS SURGERY. THE SAME DAY, THE WHITE BLOOD CELL (WBC) COUNT WAS 7010/MCL AND C-REACTIVE PROTEIN (CRP) WAS 1.8 MG/DL (NORMAL RANGE NOT PROVIDED FOR BOTH). ON (B)(6) 2011, THE PATIENT HAD PARALYTIC ILEUS, AND ILEUS TUBE WAS PLACED. ON (B)(6) 2011, ILEUS IMPROVED, AND THE ILEUS TUBE WAS REMOVED. ON (B)(6) 2011, THE PATIENT RESUMED EATING. ON (B)(6) 2011, THE SUBCUTANEOUS DRAINAGE TUBE WAS REMOVED FROM THE WOUND. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS REPORTED THAT THE HOSPITALIZATION HAD BEEN PROLONGED DUE TO THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT REHOSPITALIZED FOR TREATMENT. AS OF (B)(6) 2015, THE PATIENT HAD RECOVERED FROM THE FASCIAL DEHISCENCE WITH A SEQUELA OF VENTRAL HERNIA. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: RECOVERED. A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE 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 PASS FINAL PRODUCT AND STERILITY SPECIFICATIONS. PRODUCT SAFETY METRICS WERE COMPILED BY GENZYME/SANOFI GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY AND PRESENTED TO SENIOR MANAGEMENT. ANY TRENDING SIGNAL WAS 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 A LOT INVESTIGATION WOULD BE PERFORMED BY GENZYME-SANOFI BIOSURGERY QUALITY ASSURANCE AT THAT TIME. DIAGNOSIS: FASCIAL DEHISCENCE (ABDOMINAL WOUND DEHISCENCE) REPORTING SURGEON'S SERIOUSNESS ASSESSMENT: SERIOUS (INPATIENT/PROLONGED HOSPITALIZATION). REPORTING SURGEON'S CAUSALITY ASSESSMENT: PROBABLE. REPORTING SURGEON'S COMMENT: THE ALTERNATIVE EXPLANATION FOR THE EVENT WAS OBESITY. THE PATIENT HAD COMPLETE FASCIAL DEHISCENCE WITHOUT WOUND INFECTION IN EARLY PHASE AFTER SURGERY (ON POSTOPERATIVE DAY 10), AND IT WAS CONSIDERED THAT THERE WAS A SIGNIFICANT DISTURBANCE IN FASCIAL HEALING. OBESITY, A LARGE AMOUNT OF ASCITES, AND UNDERNUTRITION COULD HAVE INVOLVED IN THE EVENT, BUT THE POSSIBILITY OF DYSGRAPHIA DUE TO SEPRAFILM ALSO COULD NOT BE EXCLUDED. REPORTER CAUSALITY: SEPRAFILM AS POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE. FOLLOW UP WAS RECEIVED ON 10-JUL-2015. NO NEW INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION WAS RECEIVED ON 10-JUL-2015. GLOBAL PTC NUMBER AND PTC RESULTS WERE ADDED. TEXT WAS AMENDED ACCORDINGLY. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2016 FROM THE SURGEON. THE MEDICAL HISTORY, CONCURRENT CONDITION AND CONCOMITANT MEDICATIONS WERE ADDED. THE VERBATIM FOR THE EVENT WAS UPDATED FROM EARLY POSTOPERATIVE FASCIAL DEHISCENCE TO FASCIAL DEHISCENCE. THE DOSAGE AND START DATE OF THE SUSPECT PRODUCT WERE ADDED. THE EVENT START DATE WAS ADDED. THE DETAILED DESCRIPTION OF THE EVENT, EXAMINATION FINDINGS AND LABORATORY DATA WERE ADDED. THE OUTCOME WAS UPDATED FROM UNKNOWN TO RECOVERED WITH SEQUELA (VENTRAL HERNIA). THE SERIOUSNESS CRITERION WAS UPDATED FROM IMPORTANT MEDICAL EVENT TO INPATIENT/PROLONGED HOSPITALIZATION. THE REPORTING SURGEON'S COMMENT WAS ADDED. CLINICAL COURSE WAS UPDATED AND TEXT AMENDED ACCORDINGLY.
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2015 VIA CONFERENCE ABSTRACT: NISHITAI R, MANAKA D, HAMASU S, KONISHI S. FIVE CASES OF FASCIAL DEHISCENCE WITH USE OF SEPRAFILM NOTED EARLY AFTER HEPATO-BILIARY-PANCREATIC SURGERY "SPRAFILM" AS A POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE. THE 27TH MEETING OF (B)(6). FROM THIS ARTICLE, THE OTHER CASES CREATED WERE: (B)(6) (CLUSTER). THIS CASE INVOLVES A (B)(6) MALE PATIENT WHO EXPERIENCED EARLY POSTOPERATIVE FASCIAL DEHISCENCE AFTER RECEIVING TREATMENT WITH SEPRAFILM. NO PAST DRUG, CONCOMITANT MEDICATION OR CONCURRENT CONDITION WAS PROVIDED. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR OBESITY, ASYMPTOMATIC OLD CEREBRAL INFARCTION, HYPOALBUMINAEMIA WITH ALBUMIN OF 3.0 G/DL. ON AN UNKNOWN DATE, AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) TUBE WAS PLACED BEFORE SURGERY FOR SUPERFICIAL-SPREADING-TYPE CYSTIC DUCT CANCER. ON AN UNKNOWN DATE, EXTRAHEPATIC BILE DUCT RESECTION WAS PERFORMED IN UPPER ABDOMINAL MEDIAN INCISION APPROACH USING SEPRAFILM ONCE (FORMULATION, ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE: UNKNOWN) FOR HEPATO-BILIARY-PANCREATIC SURGERY. IT WAS REPORTED THAT BLOOD TRANSFUSION WAS ADMINISTERED. ON AN UNKNOWN DATE, ON POSTOPERATIVE DAY 03, THE AMOUNT OF FLUID THROUGH THE DRAIN RAPIDLY INCREASED TO 260 ML. ON AN UNKNOWN DATE, ON POSTOPERATIVE DAY 10, THE PATIENT DEVELOPED FASCIAL DEHISCENCE. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNKNOWN. SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT (IME). A PHARMACEUTICAL TECHNICAL COMPLAINT WAS INITIATED AND PTC RESULTS WERE PENDING FOR THE SAME. REPORTER CAUSALITY: SEPRAFILM AS POSSIBLE RISK FACTOR OF FASCIAL DEHISCENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 394232 | SEPRAFILM (SEPRAFILM) | BIORESORBABLE ADHESION BARRIER | MCN | GENZYME BIOSURGERY (SEPRAFILM/PACK) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| O | PREV MEDS = UNKNOWN. |