BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENAPRO HYBRID HERNIA REPAIR GRAFT

    MDR report key: 4059486 · Received August 8, 2014

    Report

    Report Number
    1835959-2014-00292
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT GENDER NOT PROVIDE. DATE OF EVENT WAS THE WEEKEND OF (B)(6) 2014. PRODUCT COMMON NAME IS HYBRID HERNIA REPAIR DEVICE. THE GRAFT WAS EXPLANTED OVER THE WEEKEND OF (B)(6) 2014. PRODUCT 510(K) IS K111695. CONCLUSIONS: ROOT CAUSE; PLEASE SEE "SUMMARY OF INVESTIGATION FINDINGS" FOR ROOT CAUSE ANALYSIS. INVESTIGATION - EVALUATION: INVESTIGATION INTO THIS FEEDBACK INCLUDED A REVIEW OF THE FEEDBACK DETAILS, A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, A REVIEW OF THE IFU, AND A MEETING OF THE INCIDENT INVESTIGATION COMMITTEE. SUMMARY OF INVESTIGATION FINDINGS: THE ROOT CAUSE OF THE REPORTED BOWEL OBSTRUCTION IS ADHESIONS WHICH THE SURGEON INDICATED WERE LIKELY CAUSED BY THE COVIDIEN ABSORBATACKS. ALTHOUGH THE SURGEON INDICATED THE COVIDIEN ABSORBATACKS AS THE CAUSE OF THE ADHESIONS, THE SURGEON ALSO INDICATED THE ABSORBATACKS DID NOT APPEAR TO HAVE HELD THE GRAFT IN PLACE. AS SUCH, WE CANNOT RULE OUT THAT THE ZENAPRO HYBRID HERNIA GRAFT DID NOT IN SOME MANNER CONTRIBUTE TO THE FORMATION OF THE ADHESIONS. THE ZENAPRO HYBRID HERNIA REPAIR DEVICE IFU DOES LIST ADHESIONS AS ONE OF THE POTENTIAL COMPLICATIONS WITH THE USE OF ANY PROSTHESIS. THE ROOT CAUSE OF THE ABSORBATACKS NOT SECURING THE GRAFT IN PLACE IS INCONCLUSIVE HOWEVER; SURGICAL TECHNIQUE MAY HAVE INFLUENCED THIS. THE IFU NOTES SEVERAL KEY POINTS RELATING TO SECUREMENT OF THE GRAFT.

    Description of Event or Problem · 1

    DR. (B)(6) PLACED A ZENAPRO HYBRID HERNIA GRAFT IN AN (B)(6) YEAR OLD PATIENT ON (B)(6) 2014. THE PROCEDURE WAS A LAPAROSCOPIC VENTRAL HERNIA REPAIR. THE PATIENT WAS REOPERATED ON OVER THE FOLLOWING WEEKEND DUE TO A BOWEL OBSTRUCTION AND THE GRAFT WAS EXPLANTED. THE REOPERATION REVEALED THE BOWEL CONSTRUCTION WAS SECONDARY TO ADHESIONS. DR. (B)(6) INDICATED THE ADHESIONS WERE LIKELY CAUSED BY THE COVIDIEN ABSORBATACKS WHICH WERE USED TO PLACE THE GRAFT AND THAT THE ABSORBATACKS DID NOT SECURE THE GRAFT WELL TO THE ABDOMINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470662 ZENAPRO HYBRID HERNIA REPAIR GRAFT GRAFT FTL COOK BIOTECH, INC. LB723202

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L COVIDIEN ABSORBATACK USED TO SECURE THE GRAFT| IMPLANT DATE: