BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® STRETCH VASCULAR GRAFT

    MDR report key: 5093115 · Received September 21, 2015

    Report

    Report Number
    2017233-2015-00635
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    July 29, 2010
    Report Date
    September 7, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K903931
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHEMESH D, GOLDIN I, HIJAZI J. A PROSPECTIVE RANDOMIZED STUDY OF HEPARIN-BONDED GRAFT (PROPATEN) VERSUS STANDARD GRAFT IN PROSTHETIC ARTERIOVENOUS ACCESS. J VASC SURG 2015;62:115-22. LOT: 7240430 (B)(4). (B)(4): MEDICATIONS: SIMVASTATIN, ASA, PLAVIX. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    IN THE MEDICAL LITERATURE, AN ARTICLE, "A PROSPECTIVE RANDOMIZED STUDY OF HEPARIN-BONDED GRAFT (PROPATEN) VERSUS STANDARD GRAFT IN PROSTHETIC ARTERIOVENOUS ACCESS." WAS REVIEWED. PATIENTS WITH END-STAGE RENAL FAILURE REQUIRING A PROSTHETIC ACCESS WERE RANDOMIZED TO RECEIVE EITHER A STANDARD EXPANDED POLYTETRAFLUROETHYLENE (EPTFE) GRAFT OR A HEPARIN-BONDED EPTFE GRAFT. PATIENTS WERE ENROLLED FROM JUNE 2007 UNTIL NOVEMBER 2011 AND WERE FOLLOWED UP UNTIL JULY 2013, WHEN THE STUDY CONCLUDED. THE PERFORMANCE OF GORE PROPATEN VASCULAR GRAFTS IN RESISTING THROMBOSIS, DECREASING EARLY FAILURE AND POSSIBLY PROLONGING PATENCY WAS ASSESSED. ON (B)(6) 2010, A PATIENT WAS IMPLANTED WITH A GORE-TEX STRETCH VASCULAR GRAFT FOR ARTERIOVENOUS ACCESS FROM THE BRACHIAL ARTERY TO THE BASILIC VEIN IN THE LEFT ARM. IT WAS REPORTED TO GORE THAT ON (B)(6) 2010, THE PATIENT PRESENTED WITH ARTERIAL STEAL SYNDROME. A REINTERVENTION PROCEDURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623966 GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 7240430

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention