BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2151548 · Received June 28, 2011

    Report

    Report Number
    2017233-2011-00322
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES. THE PROXIMAL NECK MEASURED 21-23 MM IN WIDTH. CALCIUM DEPOSITS WERE ALSO NOTED. MEASUREMENTS NOT AVAILABLE. AFTER THE GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENT WERE IMPLANTED; ANGIO REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN THEN BALLOONED (BOTH CODA AND ZMED BALLOONS WERE USED DURING THIS PROCEDURE) THE PROXIMAL NECK AND PLACED AN AORTIC EXTENDER COMPONENT. THE TYPE I ENDOLEAK PERSISTED. THE PHYSICIAN THEN IMPLANTED A PALMAZ STENT IN THE PROXIMAL END OF THE ENDOGRAFT SYSTEM. THE TYPE I ENDOLEAK WAS STILL VISIBLE. THE PHYSICIAN BALLOONED THE PROXIMAL END AGAIN. AFTERWARDS, AN AORTIC TEAR WAS NOTED. THE PHYSICIAN IMPLANTED ANOTHER AORTIC EXTENDER COMPONENT AND BALLOONED. THE EXTRAVASATION CONTINUED. THE PHYSICIAN CHOSE TO CONVERT TO OPEN REPAIR. A 16X8 DACRON BIFURCATED DEVICE WAS IMPLANTED. THE RIGHT RENAL ARTERY WAS IMPLANTED WITH A GORE-TEX GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES WLG425 7783321

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R (B)(4)| (B)(4)| (B)(4)