BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX® STRETCH VASCULAR GRAFT

    MDR report key: 3820229 · Received May 20, 2014

    Report

    Report Number
    3006215353-2014-00001
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 20, 2014
    Report Date
    May 22, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K941981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. FIELD SHOULD BE BLANK. THIS GRAFT WAS NOT EXPLANTED.

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS PENDING THE COMPLETION OF THE MANUFACTURING PAPERWORK REVIEW. VIABAHN ENDOPROSTHESIS - LOT #12045257, MFR REPORT #2017233-2014-00257. VIABAHN ENDOPROSTHESIS - LOT #12091352, MFR REPORT #2017233-2014-00258. GORE-TEX STRETCH VASCULAR GRAFT - LOT #11687160, MFR REPORT #3006215353-2014-00001. GORE PROPATEN VASCULAR GRAFT - LOT #4259301PP001, MFR REPORT #2017233-2014-00259.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE PATIENT PRESENTED WITH CLAUDICATION. BILATERAL EXTERNAL ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY OCCLUSIONS WERE IDENTIFIED. ON (B)(6) 2014, TWO GORE VIABAHN ENDOPROSTHESES WERE IMPLANTED. ON (B)(6) 2014, ANGIOGRAM REVEALED FILLING DEFECTS AND EMBOLIZATION WITH AN OCCLUSION OF THE VIABAHN DEVICE. THE PHYSICIAN SUSPECTED THE EMBOLIZATION WAS DUE TO A PREVIOUS MYOCARDIAL INFARCTION. APRIL 16, 2014, AXILLOBIFEMORAL GORE-TEX STRETCH VASCULAR GRAFT WAS IMPLANTED TO BYPASS THE OCCLUDED ILIAC VESSELS INCLUDING THE RIGHT EXTERNAL ILIAC ARTERY WHERE THE VIABAHN DEVICES WERE IMPLANTED. DISTAL ANASTOMOSIS OF THE AXILLOBIFEMORAL STRETCH VASCULAR GRAFT WAS AT THE PROFUNDA ARTERY BILATERALLY. A RIGHT ABOVE THE KNEE FEMORAL-POPLITEAL BYPASS GRAFT WAS ALSO IMPLANTED USING A GORE PROPATEN VASCULAR GRAFT. THE AXILLOBIFEMORAL GORE-TEX STRETCH GRAFT OCCLUDED ON APRIL 21, 2014. A THROMBECTOMY WAS PERFORMED TO TREAT THE VASCULAR GRAFT OCCLUSION. THE PROPATEN GRAFT WAS EXPLANTED AND REPLACED WITH A REMOVABLE RING GORE-TEX VASCULAR GRAFT. NO REPORT OF AN GRAFT OCCLUSION INVOLVING THE PROPATEN VASCULAR GRAFT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299761 GORE-TEX® STRETCH VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 11687160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention