BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE INTERING® VASCULAR GRAFT

    MDR report key: 4153368 · Received October 8, 2014

    Report

    Report Number
    2017233-2014-00520
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    July 1, 2012
    Report Date
    December 31, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K991602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DEVICE WAS RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED IN FORMALIN WERE TWO GORE INTERING VASCULAR GRAFT FRAGMENTS (VGF-1 AND VGF-2). HISTOPATHOLOGICAL EXAMINATION OF SIX CROSS SECTIONS FROM VGF-1 AND VGF-2 WAS PERFORMED. HISTOLOGICALLY THE CROSS SECTIONS FROM VGF-1 AND VGF-2 WERE DEGRADED, CONSISTENT WITH IMPROPER, OR A SIGNIFICANT DELAY IN, FIXATION. THE ABLUMINAL TISSUE OVERLYING THE GRAFT WAS COMPOSED OF MATURE COLLAGEN INTERMIXED WITH ADIPOSE TISSUE AND NERVE/MUSCLE BUNDLES WHICH IS CONSISTENT WITH A NORMAL HEALING RESPONSE FOR THIS IMPLANT TIME PERIOD. THE LUMINAL SURFACE OF THE GRAFT, WHEN COVERED, WAS COVERED IN THIN LAYER OF PROTEINACEOUS TISSUE. THE LUMEN OF THE GRAFT SECTIONS WERE WIDELY PATENT. THERE WAS NO EVIDENCE OF INFECTION. THE DEVICES WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION ALL DEVICES WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. MECHANICAL DISRUPTIONS OF THE GRAFT FRAGMENTS BY SURGICAL INSTRUMENTS, SUCH AS ELECTROCAUTERY AND CLAMPS, WERE IDENTIFIED AND LIKELY OCCURRED DURING A SURGICAL PROCEDURE. THE DISRUPTIONS IDENTIFIED WERE NOT ASSOCIATED WITH HANDLING OR MANUFACTURING PROCESS AT W.L. GORE AND ASSOCIATES.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS REPORTED TO BE AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RETURNED TO GORE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PATIENT WAS IMPLANTED WITH A GORE® INTERING® VASCULAR GRAFT IN AN AXILLARY-AXILLARY BYPASS PROCEDURE. IN (B)(6) 2012, A SEROMA FORMATION WAS OBSERVED AROUND THE GRAFT CLOSE TO THE ANASTOMOSIS SITE OF THE LEFT AXILLARY ARTERY. A SURGICAL REMOVAL OF THE SEROMA WAS PERFORMED. IT WAS REPORTED THAT ABOUT 70% WAS YELLOW TISSUE AND THE REMAINING 30% WAS SEROUS FLUID. A SEROMA LEAKAGE FROM THE GRAFT WAS NOT OBSERVED AS THE TISSUE HAD BEEN ATTACHED TO THE GRAFT. ON UNKNOWN DATE IN 2013, A SEROMA FORMATION WAS OBSERVED AROUND THE GRAFT IN THE SAME AREA. A SURGICAL REMOVAL OF THE SEROMA WAS PERFORMED. ON UNKNOWN DATE IN 2014, A SEROMA FORMATION WAS OBSERVED AROUND THE GRAFT IN THE SAME AREA. A SURGICAL REMOVAL OF THE SEROMA WAS PERFORMED. ON (B)(6) 2014, A SEROMA FORMATION WAS OBSERVED AROUND THE GRAFT IN THE SAME AREA. THE PHYSICIAN DETERMINED THAT A SURGICAL REMOVAL WOULD NOT SOLVE THE PROBLEM, AND PERFORMED AN OPEN SURGERY TO EXPLANT THE GRAFT. THE PHYSICIAN CONFIRMED THE STABLE HEMODYNAMIC AND DID NOT PLACE ANOTHER AX-AX BYPASS. AS OF (B)(6) 2014, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630728 GORE INTERING® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 9186401

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention