BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 5718402 · Received June 10, 2016

    Report

    Report Number
    1835959-2016-00199
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    July 21, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    OXK
    UDI-DI
    10827002466002
    PMA / PMN Number
    K133306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE INDICATED AS EARLY (B)(6) 2016. EXPLANT DATE INDICATED AS ELEVEN DAYS POST-OP. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND THAT TWO DEVICES WERE PRODUCED IN THIS LOT. A REVIEW OF THE (B)(4) COMPLAINT DATABASE DID NOT REVEAL ANY OTHER COMPLAINTS RELATING TO THIS LOT. SINCE A MEMBER OF THE CLINICAL STUDY STAFF INDICATED THE "COMPLICATION MAY HAVE BEEN RELATED TO THE MESH," AN MDR WILL BE FILED. HOWEVER, THIS COMPLAINT IS STILL UNDER INVESTIGATION. COMMUNICATION ATTEMPTS WITH THE SURGEON ARE ONGOING IN AN EFFORT TO CLARIFY / CONFIRM IF THE BIODESIGN HERNIA GRAFT WAS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THE FORMATION OF THE FISTULA AND / OR THE NEED FOR INTERVENTION. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL DETAILS ARE OBTAINED. UPDATE: ON 06/30/2016, A REPRESENTATIVE AT THE STUDY SITE REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE BIODESIGN HERNIA GRAFT CONTRIBUTED TO OR CAUSED THE FORMATION OF THE FISTULA. THE MANUFACTURER IS STILL AWAITING THE FINAL REPORT OF THE HISTOPATHOLOGY EVALUATION. UPDATE #2: IN RELATION TO THE HISTOPATHOLOGY REPORT, BACTERIAL COLONIES WERE NOT NOTED ON THE HEMATOXYLIN AND EOSIN (HE) STAIN, BUT THEY ARE REPORTEDLY DIFFICULT TO CONFIRM WITH HE STAIN. THE RESULTS ARE POTENTIALLY INDICATIVE OF A BACTERIAL INFECTION. GIVEN THE NATURE OF THE ORIGINAL SURGERY PERFORMED, WITH THE PLACEMENT OF THE BIODESIGN GRAFT, AND THE OCCURRENCE OF A FISTULA, INFECTION IS A PROBABLE OCCURRENCE. THE BIODESIGN HERNIA GRAFT WAS NOT ALLEGED TO BE THE SOURCE OF AN INFECTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE INDICATED AS EARLY (B)(6) 2016. EXPLANT DATE INDICATED AS ELEVEN DAYS POST-OP. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND THAT TWO DEVICES WERE PRODUCED IN THIS LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY OTHER COMPLAINTS RELATING TO THIS LOT. SINCE A MEMBER OF THE CLINICAL STUDY STAFF INDICATED THE "COMPLICATION MAY HAVE BEEN RELATED TO THE MESH," AN MDR WILL BE FILED. HOWEVER, THIS COMPLAINT IS STILL UNDER INVESTIGATION. COMMUNICATION ATTEMPTS WITH THE SURGEON ARE ONGOING IN AN EFFORT TO CLARIFY / CONFIRM IF THE BIODESIGN HERNIA GRAFT WAS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THE FORMATION OF THE FISTULA AND / OR THE NEED FOR INTERVENTION. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL DETAILS ARE OBTAINED. UPDATE: ON 06/30/2016, A REPRESENTATIVE AT THE STUDY SITE REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE BIODESIGN HERNIA GRAFT CONTRIBUTED TO OR CAUSED THE FORMATION OF THE FISTULA. THE MANUFACTURER IS STILL AWAITING THE FINAL REPORT OF THE HISTOPATHOLOGY EVALUATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE INDICATED AS EARLY (B)(6) 2016. EXPLANT DATE INDICATED AS ELEVEN DAYS POST-OP. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND THAT TWO DEVICES WERE PRODUCED IN THIS LOT. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY OTHER COMPLAINTS RELATING TO THIS LOT. SINCE A MEMBER OF THE CLINICAL STUDY STAFF INDICATED THE "COMPLICATION MAY HAVE BEEN RELATED TO THE MESH," AN MDR WILL BE FILED. HOWEVER, THIS COMPLAINT IS STILL UNDER INVESTIGATION. COMMUNICATION ATTEMPTS WITH THE SURGEON ARE ONGOING IN AN EFFORT TO CLARIFY / CONFIRM IF THE BIODESIGN HERNIA GRAFT WAS ALLEGED TO HAVE CAUSED OR CONTRIBUTED TO THE FORMATION OF THE FISTULA AND / OR THE NEED FOR INTERVENTION. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL DETAILS ARE OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL FOR ELECTIVE TAKEDOWN OF BROOKE'S ILEOSTOMY AND FORMATION OF A NEW KOCK POUCH. IN EARLY (B)(6) THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, CONVERSION OF BROOKE END ILEOSTOMY TO KOCK POUCH, MIDLINE INCISIONAL HERNIA REPAIR WITH BIODESIGN HERNIA GRAFT AND BILATERAL STENT PLACEMENT. THE DEFECT SIZE WAS 5 CM BY 15 CM. FOUR DAYS POST-OP THE JP DRAIN IN HIS RIGHT LOWER QUADRANT WAS REMOVED. ON (B)(6) 2016 THE PATIENT HAD A FEVER TO 38.5 DEGREES CELSIUS (101.3 DEGREES FAHRENHEIT) . DESPITE THIS HE FELT WELL. A CT SCAN WAS DONE WHICH SHOWED A FISTULA BETWEEN KOCK POUCH AND MIDLINE INCISION. TEN DAYS POST-OP THE PATIENT UNDERWENT A FLUOROSCOPY DRAIN STUDY TO FURTHER CHARACTERIZE THE FISTULA. HE WAS SUBSEQUENTLY PREPPED FOR THE OPERATING ROOM. ELEVEN DAYS POST-OP THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND UNDERWENT EXPLORATORY LAPAROTOMY WITH EXCISION OF THE PARTIALLY DISSOLVED AND FRAGMENTED BIODESIGN HERNIA GRAFT AND CREATION OF A DIVERTING LOOP ILEOSTOMY. UPDATE: ON 06/30/2016, A REPRESENTATIVE AT THE STUDY SITE REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE BIODESIGN HERNIA GRAFT CONTRIBUTED TO OR CAUSED THE FORMATION OF THE FISTULA.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL FOR ELECTIVE TAKEDOWN OF BROOKE'S ILEOSTOMY AND FORMATION OF A NEW KOCK POUCH. IN EARLY MARCH THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, CONVERSION OF BROOKE END ILEOSTOMY TO KOCK POUCH, MIDLINE INCISIONAL HERNIA REPAIR WITH BIODESIGN HERNIA GRAFT AND BILATERAL STENT PLACEMENT. THE DEFECT SIZE WAS 5 CM BY 15 CM. FOUR DAYS POST-OP THE JP DRAIN IN HIS RIGHT LOWER QUADRANT WAS REMOVED. ON (B)(6) 2016 THE PATIENT HAD A FEVER TO 38.5 DEGREES CELSIUS (101.3 DEGREES FAHRENHEIT) . DESPITE THIS HE FELT WELL. A CT SCAN WAS DONE WHICH SHOWED A FISTULA BETWEEN KOCK POUCH AND MIDLINE INCISION. TEN DAYS POST-OP THE PATIENT UNDERWENT A FLUOROSCOPY DRAIN STUDY TO FURTHER CHARACTERIZE THE FISTULA. HE WAS SUBSEQUENTLY PREPPED FOR THE OR. ELEVEN DAYS POST-OP THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND UNDERWENT EXPLORATORY LAPAROTOMY WITH EXCISION OF THE PARTIALLY DISSOLVED AND FRAGMENTED BIODESIGN HERNIA GRAFT AND CREATION OF A DIVERTING LOOP ILEOSTOMY. UPDATE: ON 06/30/2016, A REPRESENTATIVE AT THE STUDY SITE REPORTED THAT THE SURGEON DID NOT BELIEVE THAT THE BIODESIGN HERNIA GRAFT CONTRIBUTED TO OR CAUSED THE FORMATION OF THE FISTULA.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE HOSPITAL FOR ELECTIVE TAKEDOWN OF BROOKE'S ILEOSTOMY AND FORMATION OF A NEW KOCK POUCH. IN EARLY (B)(6), THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, CONVERSION OF BROOKE END ILEOSTOMY TO KOCK POUCH, MIDLINE INCISIONAL HERNIA REPAIR WITH BIODESIGN HERNIA GRAFT AND BILATERAL STENT PLACEMENT. THE DEFECT SIZE WAS 5 CM BY 15 CM. FOUR DAYS POST-OP, THE JP DRAIN IN HIS RIGHT LOWER QUADRANT WAS REMOVED. ON (B)(6) 2016, THE PATIENT HAD A FEVER TO 38.5 DEGREES CELSIUS (101.3 DEGREES FAHRENHEIT) . DESPITE THIS HE FELT WELL. A CT SCAN WAS DONE WHICH SHOWED A FISTULA BETWEEN KOCK POUCH AND MIDLINE INCISION. TEN DAYS POST-OP THE PATIENT UNDERWENT A FLUOROSCOPY DRAIN STUDY TO FURTHER CHARACTERIZE THE FISTULA. HE WAS SUBSEQUENTLY PREPPED FOR THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373370 BIODESIGN HERNIA GRAFT HERNIA GRAFT OXK COOK BIOTECH 10827002466002

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention