BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 6101443 · Received November 15, 2016

    Report

    Report Number
    2017233-2016-00868
    Event Type
    Death
    Date Received
    November 15, 2016
    Date of Event
    November 16, 2013
    Report Date
    October 18, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4). THE DEVICE REMAINS IMPLANTED, SO NO ENGINEERING INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN AORTIC ANEURYSM WITH A SIZE OF 59MM, WHICH WAS TREATED WITH A GORE-TEX® BIFURCATED VASCULAR GRAFT SUTURED INTO THE LEFT COMMON ILIAC AND HEPATIC ARTERY DURING AN ACUTE EMERGENCY PROCEDURE. IN ADDITION ONE GORE® HYBRID VASCULAR GRAFT WAS IMPLANTED INTO THE SUPERIOR MESENTERIC ARTERY AND TWO GRAFTS WERE IMPLANTED INTO THE RENAL ARTERIES. AFTER THE THREE GORE® HYBRID VASCULAR GRAFTS WERE SUTURED TO THE GORE-TEX® BIFURCATED VASCULAR GRAFT THE ENTIRE VASCULAR GRAFT SYSTEM WAS COVERED WITH A BOVINE (COW) PATCH. FOLLOWING THE PROCEDURE, THE DIAGNOSED AORTIC ANEURYSM WAS EXCLUDED. IN (B)(6) THE PATIENT DEVELOPED A PERIGRAFT SEROMA. THE PERIGRAFT SEROMA WAS DETECTED UNDER THE BOVINE PATCH AND SURROUNDED ALL IMPLANTED GORE VASCULAR GRAFTS. THE PHYSICIAN IS NOT ABLE TO TELL IF ONE OR SEVERAL OF THE GRAFTS OR THE BOVINE PATCH HAVE CAUSED THE PERIGRAFT SEROMA. THE COMPLAINANT STATED THAT ALL VASCULAR GRAFTS WERE PATENT DURING A COMPUTER TOMOGRAPHY WHICH WAS PERFORMED ON (B)(6) 2013. THE PATIENT WAS REOPERATED ON (B)(6) 2013, TO EVACUATE THE GELATINOUS PERIGRAFT SEROMA. DURING THE PERFORMED RE-INTERVENTION, IN ORDER TREAT THE PERIGRAFT SEROMA, THE PATIENT DEVELOPED A SEVERE BLEEDING. ON (B)(6) 2013, THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE. SO THE PHYSICIAN STATED THAT THE DEVELOPED PERIGRAFT SEROMA CAUSED THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753441 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 11307852

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death