BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5273942 · Received December 8, 2015

    Report

    Report Number
    2017233-2015-00865
    Event Type
    Death
    Date Received
    December 8, 2015
    Date of Event
    November 13, 2014
    Report Date
    January 29, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES RETURNED FOR EVALUATION, ADDED DATE DEVICES RETURNED. CONCOMITANT MEDICAL PRODUCTS: PATIENT MEDICATIONS INCLUDE; BISOPROLOL, PLAVIX, GLICLAZIDE, LANTUS, PANTOPRAZOLE, SIMVASTATIN AND METFORMIN. EVALUATION SUMMARY-THE DEVICES WERE RETURNED TO W. L. GORE & ASSOCIATES FOR INVESTIGATION. SUBMITTED IN FORMALIN WERE TWO GORE EXCLUDER AAA ENDOPROSTHESES; ONE TRUNK ¿ IPSILATERAL LEG ENDOPROSTHESES (TRUNK) AND ONE CONTRALATERAL LEG ENDOPROSTHESIS (CL). THE LUMENS OF BOTH DEVICES WERE WIDELY PATENT. LUMINAL, ABLUMINAL, AND CONSTRAINT SLEEVE SURFACES WERE GENERALLY DEVOID OF TISSUE EXCEPT FOR SCATTERED PLAQUES OF FRIABLE RED BROWN TISSUE THAT WAS CONSISTENT WITH RESIDUAL DRIED BLOOD. A MODERATE AMOUNT OF THIN, LIGHT TAN TO BROWN, HARD TISSUE WAS FIRMLY ADHERED TO THE ABLUMINAL SURFACE ALONG THE PROXIMAL EDGE OF THE TRUNK COMPONENT. THERE WAS AN APPROXIMATELY 4MM HOLE LOCATED ON THE TRUNK COMPONENT NEAR THE BIFURCATION. HISTOPATHOLOGICAL EXAMINATION OF ONE ABLUMINAL TISSUE SPECIMEN FROM THE PROXIMAL TRUNK WAS PERFORMED. THE ABLUMINAL LIGHT TAN TO BROWN HARD TISSUE WAS CONSISTENT WITH ATHEROSCLEROTIC ARTERY. THERE WAS NO EVIDENCE OF INFECTION. THE DEVICES WERE SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION ALL DEVICES WERE EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. ONE WEAR RELATED DISRUPTION WAS IDENTIFIED; ONE WIRE DISCONTINUITY OF THE TRUNK IPSILATERAL LEG. THE WIRE DISCONTINUITY IS CONSISTENT WITH A FATIGUE FRACTURE DUE TO EXCESSIVE LOADING. THREE HOLES (2 OF CL AND 1 OF TRUNK) WERE IDENTIFIED. THE THREE HOLES ARE CONSISTENT WITH PUNCTURE OF THE GRAFT MATERIAL BY A SHARP SURGICAL INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT HAS BEEN CHANGED BASED ON NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: PXC201400/10223418. RMT281418/10328135: (B)(4); PXC201400/10223418: (B)(4).

    Description of Event or Problem · 1

    PREVIOUS INTERVENTIONS: ON (B)(6) 2014 INTERVENTION: SUCCESSFUL COILING OF THE RIGHT LUMBAR ARTERY, BUT FAILURE TO COIL THE LEFT LUMBAR ARTERY; ON (B)(6) 2015 INTERVENTION: ANOTHER FAILED ATTEMPT TO COIL THE LEFT LUMBAR ARTERY; ON (B)(6) 2015: MEETING TO DISCUSS THE NEXT INTERVENTION TO LIGATE THE LEFT LUMBAR ARTERY AND THE INFERIOR MESENTERIC ARTERY (IMA) BY OPENING THE ANEURYSM SAC. PATIENT WAS INFORMED ABOUT THE POSSIBILITY THAT THE GORE EXCLUDER ENDOPROSTHESES MIGHT NEED TO BE REMOVED AND THAT A CONVERSION TO A DACRON DEVICE IS POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. A PERSISTENT TYPE II ENDOLEAK, CAUSED BY BIG LUMBAR ARTERIES, HAD CAUSED AN AORTIC ANEURYSM GROWTH FROM 62MM AT THE TIME OF IMPLANTATION TO 80MM. AFTER MULTIPLE ATTEMPTS TO COIL THE LUMBAR ARTERIES HAD FAILED, THE PATIENT WAS TREATED WITH OPEN PROCEDURE ON (B)(6) 2015. THE ANEURYSMAL SAC WAS OPENED AND THE LUMBAR ARTERIES WERE LIGATED. WHILE CLOSING THE ANEURYSMAL SAC, A SEVERE BLEEDING FROM THE GORE EXCLUDER AAA ENDOPROSTHESES OCCURRED. ACCORDING TO THE PHYSICIAN THE NITINOL WIRE OF THE DEVICE WAS FRACTURED. THIS PROBABLY PUNCTURED THE EPTFE GRAFT MATERIAL. DUE TO THIS, THE GORE EXCLUDER AAA ENDOPROSTHESES WAS EXPLANTED AND A BRANCHED DACRON STENT WAS SUTURED IN. DURING THE PROCEDURE THE PATIENT RECEIVED BLOOD TRANSFUSION VIA AN INTRAOPERATIVE BLOOD SALVAGE DEVICE. DUE TO EXTENSIVE BLOOD LOSS (35L) AND SUPRARENAL CLAMPING MULTIPLE ORGAN FAILURE OCCURRED AND THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806048 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10328135

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death