BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1892372 · Received November 2, 2010

    Report

    Report Number
    2017233-2010-00487
    Event Type
    Death
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED, BUT NOT YET COMPLETED. METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A (B)(6) MALE PT WAS TAKEN TO THE CATH LAB FOR ELECTIVE PLACEMENT OF A MEDTRONIC AORTO-UNILIAC STENT GRAFT INSIDE OF A PRE-EXISTING AORTIC BIFURCATION STENT GRAFT DUE TO AN ENDOLEAK. DURING THE SAME PROCEDURE, THE PT RECEIVED A RIGHT-TO-LEFT FEMOROFEMORAL ARTERIAL BYPASS GRAFT USING A GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING) DUE TO A LEFT ILIAC OCCLUSION. THE PROCEDURE WAS COMPLETED AND THE PT LEFT THE CATH LAB WITH PULSES DETECTED IN THE LEFT LEG. IT WAS REPORTED TO GORE THAT ON (B)(6) 2010, THE PT HAD PALPABLE PULSES IN THE LEFT LEG AND THE DRESSING ON THE LEFT GROIN WAS BLOODIER THAN USUAL. LATER THAT SAME DAY THE PT'S CONDITION DETERIORATED AND THE LEFT LEG WENT COLD AND WAS WITHOUT PULSES. THE PT WAS TAKEN TO THE OPERATING ROOM EMERGENTLY AND THE LEFT GROIN INCISION WAS RE-OPENED. A LARGE HEMATOMA WAS OBSERVED. IT WAS REPORTED THAT THE DISTAL PORTION OF THE GRAFT, WHERE THE RINGS HAD BEEN REMOVED, WAS COMPLETELY DISRUPTED (TRANSECTED), APPROXIMATELY 1 CM PROXIMAL TO THE ANASTOMOSIS. THE BLOOD WAS FLOWING FROM THE DISTAL SECTION OF THE GRAFT WHICH WAS ANASTOMOSED TO THE LEFT COMMON FEMORAL ARTERY. AFTER THE BLEEDING WAS CONTROLLED, THE CENTRAL PORTION OF THE GORE GRAFT WAS EXPLANTED. IT WAS FURTHER REPORTED THAT A NON-GORE VASCULAR GRAFT WAS IMPLANTED TO REPLACE THE GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING). IT WAS REPORTED THAT THE PT WAS GOING INTO SHOCK DURING THE REOPERATION. THE PT LEFT THE OPERATING ROOM WITH PULSES IN THE LEFT LEG BUT WAS NOT DOING WELL. ON (B)(6) 2010, THE PT EXPIRED. APPARENTLY, ACCORDING TO THE NURSE, THE PT HAD PULSES IN THE LEFT LEG UP TO THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES WLG450 3188383PP020

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death MEDTRONIC AORTO-UNILIAC STENT GRAFT| VASCULAR GRAFT (UNK MFR)