BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN HERNIA GRAFT

    MDR report key: 7664320 · Received July 5, 2018

    Report

    Report Number
    1835959-2018-00009
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    June 20, 2018
    Report Date
    September 5, 2018
    Manufacturer
    COOK BIOTECH
    Product Code
    OXK
    UDI-DI
    10827002360331
    PMA / PMN Number
    K133306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. A TOTAL OF TWO DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. ADHESION IS NOTED AMONGST THE LIST OF POTENTIAL COMPLICATIONS PROVIDED IN THE IFU. THE ROOT CAUSE, OF THE REPORTED DEVICE ADHESION TO THE SMALL BOWEL, IS INCONCLUSIVE AT THIS TIME. A SPECIMEN WAS RETURNED TO CBI AND WILL BE SENT FOR HISTOPATHOLOGY TESTING. A FOLLOW-UP MDR AND ROOT CAUSE SUMMARY WILL BE DOCUMENTED ONCE RESULTS OF THE HISTOPATHOLOGY TESTING ARE RECEIVED. UPDATE #1: ADHESIONS AND PORTIONS OF SIS WERE IDENTIFIABLE IN THE EXAMINED SPECIMEN. ADHESIONS ARE A KNOWN POTENTIAL COMPLICATION OF MOST ABDOMINAL PROCEDURES. THE ROOT CAUSE OF THE ADHESIONS IS INCONCLUSIVE. HOWEVER, MANY FACTORS CAN INFLUENCE AND CONTRIBUTE TO ADHESION FORMATION INCLUDING, BUT NOT LIMITED TO, A PATIENT'S TENDENCY TO FORM ADHESIONS, AN ABDOMINAL PROCEDURE, ANY DAMAGE TO THE BOWEL DURING THE INITIAL SURGERY, EXCESSIVE TISSUE INCISIONS, HISTORY OF PRIOR SURGERIES, EXCESSIVE HANDLING OF VISCERA, POST-OPERATIVE ACTIVITIES, NUTRITION, AND THE OVERALL STATE OF HEALTH OF THE PATIENT. IT IS POSSIBLE THAT THE FOREIGN SUTURE MATERIAL FOUND IN THE SPECIMEN CONTRIBUTED TO THE ADHESIONS AND LACK OF COMPLETE DEVICE INCORPORATION. HOWEVER, THIS CANNOT BE CONFIRMED NOR RULED OUT. LASTLY, THE SIS MAY NOT HAVE FULLY REMODELED DUE TO THE ADHESION FORMATIONS. THIS ALSO CANNOT BE CONFIRMED NOR RULED OUT. UPDATE #2: THE SUMMARY IN UPDATE #1 REMAINS PERTINENT. MEDICAL RECORDS INDICATED THE PATIENT HAD A HISTORY OF ABDOMINAL SURGERIES AND ADHESIONS.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. A TOTAL OF TWO DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. ADHESION IS NOTED AMONGST THE LIST OF POTENTIAL COMPLICATIONS PROVIDED IN THE IFU. THE ROOT CAUSE, OF THE REPORTED DEVICE ADHESION TO THE SMALL BOWEL, IS INCONCLUSIVE AT THIS TIME. A SPECIMEN WAS RETURNED TO CBI AND WILL BE SENT FOR HISTOPATHOLOGY TESTING. A FOLLOW-UP MDR AND ROOT CAUSE SUMMARY WILL BE DOCUMENTED ONCE RESULTS OF THE HISTOPATHOLOGY TESTING ARE RECEIVED. UPDATE: ADHESIONS AND PORTIONS OF SIS WERE IDENTIFIABLE IN THE EXAMINED SPECIMEN. ADHESIONS ARE A KNOWN POTENTIAL COMPLICATION OF MOST ABDOMINAL PROCEDURES. THE ROOT CAUSE OF THE ADHESIONS IS INCONCLUSIVE. HOWEVER, MANY FACTORS CAN INFLUENCE AND CONTRIBUTE TO ADHESION FORMATION INCLUDING, BUT NOT LIMITED TO A PATIENT'S TENDENCY TO FORM ADHESIONS, AN ABDOMINAL PROCEDURE, ANY DAMAGE TO THE BOWEL DURING THE INITIAL SURGERY, EXCESSIVE TISSUE INCISIONS, HISTORY OF PRIOR SURGERIES, EXCESSIVE HANDLING OF VISCERA, POST-OPERATIVE ACTIVITIES, NUTRITION, AND THE OVERALL STATE OF HEALTH OF THE PATIENT. IT IS POSSIBLE THAT THE FOREIGN SUTURE MATERIAL FOUND IN THE SPECIMEN CONTRIBUTED TO THE ADHESIONS AND LACK OF COMPLETE DEVICE INCORPORATION. HOWEVER, THIS CANNOT BE CONFIRMED NOR RULED OUT. LASTLY, THE SIS MAY NOT HAVE FULLY REMODELED DUE TO THE ADHESION FORMATIONS. THIS ALSO CANNOT BE CONFIRMED NOR RULED OUT.

    Description of Event or Problem · 0

    IN (B)(6) 2015, DR. (B)(6) PLACED A BIODESIGN HERNIA GRAFT FOR REPAIR OF AN INCISIONAL HERNIA. IN 2018, THE PATIENT WAS SEEN FOR COMPLAINTS OF PAIN. DR. (B)(6) REOPERATED AND FOUND THE DEVICE ADHERED TO THE SMALL BOWEL, NOT INCORPORATED, AND CRUMPLED. THE DEVICE WAS REPORTEDLY EXPLANTED. UPDATE #1: AN EXPLANTED SPECIMEN WAS RECEIVED AT CBI ON 07/03/2018. THE SPECIMEN UNDERWENT HISTOPATHOLOGY TESTING BY COOK RESEARCH INCORPORATED'S VETERINARY PATHOLOGIST. THE TESTING REVEALED THAT PARTIALLY REMODELED SIS WAS IDENTIFIED AMONGST THE FIBROFATTY TISSUE AND AGGREGATES. THE SIS WAS MOSTLY SURROUNDED BY MATURE FIBROUS CONNECTIVE TISSUE. THE SIS CONTAINED A FEW FIBROUS CONNECTIVE TISSUE BANDS. INFLAMMATION WAS MINIMAL AND COMPOSED OF FEW LYMPHOCYTES AND PLASMA CELLS AND RARE GRANULOCYTES USUALLY IN THE CONNECTIVE TISSUE SURROUNDING THE SIS. SURROUNDING THE SIS, DENSE MATURE CONNECTIVE TISSUE CONTAINED STIFF BLACK SUTURE-LIKE MATERIAL. NO SUTURES WERE IDENTIFIED WITHIN THE SIS. UPDATE #2: ADDITIONAL DETAILS WERE RECEIVED. PER THE PATIENT'S MEDICAL RECORDS, THE FOLLOWING DETAILS WERE OBTAINED. ON (B)(6) 2015: A CT SCAN REVEALED A LARGE HERNIA DEFECT IN THE INFRAUMBILICAL ANTERIOR ABDOMINAL WALL. THE DEFECT HAD A TRANSVERSE DIMENSION OF APPROXIMATELY 7.8 CM AND A CRANIOCAUDAL EXTENT OF APPROXIMATELY 11.5 CM. THERE WAS HERNIATION OF MESENTERY, OMENTUM, SMALL BOWEL AND A PORTION OF THE LARGE BOWEL INTO THE DEFECT. THE CONTENT OF THE HERNIA SAC EXTENDED PREDOMINANTLY TO THE RIGHT OF MIDLINE. A LINEAR DENSITY WAS NOTED ANTERIOR TO THE HERNIA, WHICH MAY HAVE REPRESENTED PREVIOUS MESH, HOWEVER CORRELATION WITH CLINICAL FEATURES WAS SUGGESTED. ADDITIONALLY, A WELL DEFINED CYST MEASURING 2.9 X 2.7 CM WAS NOTED ON THE RIGHT OVARY. ON (B)(6) 2015: ON (B)(6) 2015, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR WITH COMPONENT SEPARATION. THE REASON FOR SURGERY WAS A RECURRENT INCISIONAL HERNIA. A 10X7 CM DEFECT WAS PRESENT IN THE INFRAUMBILICAL REGION. BIODESIGN WAS PLACED INTRAPERITONEALLY. A PROLENE MESH WAS PLACED ABOVE THE RECTUS SHEATH. TWO DRAINS WERE PLACED, FLAPS WERE RAISED, AND THE INCISION WAS CLOSED IN LAYERS. THE PATIENT WAS DISCHARGED ON (B)(6) 2015. ON (B)(6) 2018: A CT SCAN WAS PERFORMED AND THE IMPRESSION WAS AN ESSENTIALLY NORMAL STUDY OF THE WHOLE ABDOMEN. THE SMALL AND LARGE BOWEL LOOPS WERE NORMAL IN CALIBER AND DISTRIBUTION. THE COLON WAS LOADED WITH AIR MIXED RESIDUE. THERE WAS NO DEFINITE STRICTURE FORMATION OR BOWEL OBSTRUCTION NOTED. ON (B)(6) 2018: THE PATIENT PRESENTED WITH COMPLAINTS OF VOMITING AND ABDOMINAL PAIN FOR ONE MONTH AND ABDOMINAL DISTENTION WITH CONSTIPATION. THE VOMITING OCCURRED IMMEDIATELY AFTER MEALS. THE ABDOMINAL PAIN WAS IN THE MID EPIGASTRIC TO CHEST REGION. ON(B)(6) 2018, THE PATIENT UNDERWENT A LAPAROSCOPIC ADHESIOLYSIS. FINDINGS FROM THE PROCEDURE INCLUDED ADHESIONS AROUND THE UMBILICUS AND MULTIPLE ILEO-ILEAL INTUSSUSCEPTION. THE ADHESIONS WERE TAKEN DOWN AND THE INTUSSUSCEPTION WAS RELIEVED. A SPECIMEN WAS SENT FOR PATHOLOGY. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL AND DISCHARGED ON (B)(6) 2018.

    Description of Event or Problem · 0

    IN (B)(6) 2015, DR. (B)(6) PLACED A BIODESIGN HERNIA GRAFT FOR REPAIR OF AN INCISIONAL HERNIA. IN 2018, THE PATIENT WAS SEEN FOR COMPLAINTS OF PAIN. DR. (B)(6) REOPERATED AND FOUND THE DEVICE ADHERED TO THE SMALL BOWEL, NOT INCORPORATED, AND CRUMPLED. THE DEVICE WAS REPORTEDLY EXPLANTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. A TOTAL OF TWO DEVICES WAS PRODUCED FROM THE LOT. A REVIEW OF THE CBI COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. ADHESION IS NOTED AMONGST THE LIST OF POTENTIAL COMPLICATIONS PROVIDED IN THE IFU. THE ROOT CAUSE, OF THE REPORTED DEVICE ADHESION TO THE SMALL BOWEL, IS INCONCLUSIVE AT THIS TIME. A SPECIMEN WAS RETURNED TO CBI AND WILL BE SENT FOR HISTOPATHOLOGY TESTING. A FOLLOW-UP MDR AND ROOT CAUSE SUMMARY WILL BE DOCUMENTED ONCE RESULTS OF THE HISTOPATHOLOGY TESTING ARE RECEIVED.

    Description of Event or Problem · 1

    IN (B)(6) 2015, DR. (B)(6) PLACED A BIODESIGN HERNIA GRAFT FOR REPAIR OF AN INCISIONAL HERNIA. IN 2018, THE PATIENT WAS SEEN FOR COMPLAINTS OF PAIN. DR. (B)(6) REOPERATED AND FOUND THE DEVICE ADHERED TO THE SMALL BOWEL, NOT INCORPORATED, AND CRUMPLED. THE DEVICE WAS REPORTEDLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506758 BIODESIGN HERNIA GRAFT HERNIA GRAFT OXK COOK BIOTECH G36033 LB763019 10827002360331

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention NONE WERE REPORTED BY THE COMPLAINANT.| NONE WERE REPORTED BY THE COMPLAINANT.| PROLENE MESH ON (B)(6) 2015| NONE WERE REPORTED BY THE COMPLAINANT.