BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    MDR report key: 5253978 · Received November 30, 2015

    Report

    Report Number
    1835959-2015-00253
    Event Type
    Injury
    Date Received
    November 30, 2015
    Report Date
    November 24, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMMON NAME IS SURGICAL MESH; PRODUCT CODE IS FTL. THE 510(K) IS K111695. 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, AND NUTRITION. ADHESION FORMATION AND BOWEL OBSTRUCTION ARE LISTED AS A POTENTIAL COMPLICATION IN THE IFU.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN OPEN REPAIR OF AN INCISIONAL HERNIA, WITH PLACEMENT OF A ZENAPRO DEVICE ON (B)(6) 2015. THE ZENAPRO DEVICE WAS PLACED INSIDE THE ABDOMEN AND SEWN TO THE UNDERSURFACE OF THE FASCIA WITH #1 PROLENE INTERRUPTED SUTURES IN A VERTICAL MATTRESS FASHION. THE HERNIA SAC WAS REAPPROXIMATED OVER THE MESH WITH INTERRUPTED 0 VICRYL SUTURES. TWO #19 BLAKE DRAINS WERE PLACED IN THE DEAD SPACE. THE SUBCUTANEOUS TISSUES WERE REAPPROXIMATED WITH 0 VICRYL INTERRUPTED SUTURES. THE SKIN WAS CLOSED WITH STAPLES. ON (B)(6) 2015, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. EXTENSIVE LYSIS OF ADHESIONS, A PARTIAL OMENTECTOMY, AND REMOVAL OF THE ZENAPRO DEVICE DUE TO A COMPLETE BOWEL OBSTRUCTION AND ADHESIONS. DURING THE OPERATION, THE SURGEON FOUND THAT THERE WAS OMENTUM AND INTESTINES ADHERENT TO THE ANTERIOR ABDOMINAL WALL THROUGHOUT THE LENGTH OF THE MESH. THE PATIENT HAD A COMPLETE BOWEL OBSTRUCTION IN THE AREA WHERE THE SMALL INTESTINE WAS ADHERENT TO THE DEVICE. AFTER THE MESH WAS DISCONNECTED FROM THE ANTERIOR ABDOMINAL WALL, THE SURGEON DISSECTED THE MESH AWAY FROM THE SMALL INTESTINE. MULTIPLE SEROSAL TEARS OCCURRED AND WERE REPAIRED WITH INTERRUPTED 2-0 SILK POP-OFF SUTURES. THE OMENTUM WAS ALSO ADHERENT TO THE MESH AND A PARTIAL OMENTECTOMY WAS PERFORMED. ADDITIONALLY, THE GREATER CURVATURE OF THE STOMACH WAS ALSO ADHERENT TO THE MESH AND WAS DISSECTED FREE USING ELECTROCAUTERY AND SHARP DISSECTION. A LYSIS OF ADHESIONS WAS PERFORMED IN THE PORTION OF THE SMALL INTESTINE THAT WAS ADHERED TO THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786228 ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT FTL COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NONE REPORTED BY THE COMPLAINANT.