BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIX ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 382214 · Received March 14, 2002

    Report

    Report Number
    2952368-2002-00051
    Event Type
    Injury
    Date Received
    March 14, 2002
    Date of Event
    December 5, 2001
    Report Date
    February 13, 2002
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC AVE RECEIVED THE EXPLANTED STENT GRAFT ON 2/25/2002. THE ANALYSIS OF THE EXPLANTED STENT GRAFT HAS BEEN COMPLETED. IT IS LIKELY THAT THE AORTIC ANGULATION CONTRIBUTED TO THE EVENTUAL "KINKING" OF THE CUFFS AND SUBSEQUENT SEPARATION OF THE COMPONENTS. IT IS NOT LIKELY THAT THE STENT BREAKS CONTRIBUTED TO THE ANEURYSM MIGRATION, AS THEY WERE NOT IN THE SEALZONE. THE ABRASION INDUCED HOLES AND WEAVE DEFORMATION CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE INCREASE IN ANEURYSM DIAMETER, THOUGH THE PHYSICIAN DID NOT MAKE NOTE OF ANY TRANSGRAFT LEAKING AT EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED BY MEDTRONIC AVE HAS CONFIRMED THAT MFR REPORT NUMBER 2952368-2002-00051 IS THE SAME PT AS MFR REPORT NUMBER 2953738-2001-00109.

    Description of Event or Problem · 1

    A 24 MM DIAMETER X 14 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 1998. ANEURYSM DIAMETER WAS REPORTED TO BE 54 MM. AT IMPLANT, THE RUNNERS WERE REPORTED TO HAVE CAUGHT THE STENT GRAFT, REQUIRING THE PLACEMENT OF TWO AORTIC CUFFS TO ENSURE A PROXIMAL SEAL. COMPUTERIZED TOMOGRAPHY (CT) SCANS PERFORMED PRIOR TO THE PATIENT'S DISCHARGE SHOWED NO MOVEMENT OF THE STENT GRAFT. A 6-MONTH CT SCAN IN 1999 DEMONSTRATED NORMAL FINDINGS AND A REDUCTION IN AUEURYSM SAC SIZE TO 49 MM IN DIAMETER. IN 2001, A CT SCAN REVEALED A KINK AT THE POINT OF CONTACT BETWEEN THE AORTIC CUFFS AND THE BIFURCATED STENT GRAFT. IT WAS REPORTED THAT THE STENT GRAFT HAD MIGRATED 4 MM FROM THE RENAL LANDING ZONE AND THAT THE ANEURYSM DIAMETER HAD INCREASED TO 59 MM. SIX MONTHS LATER, THE AORTIC CUFFS WERE FOUND TO BE DISLOCATED FROM THE MAIN STENT BODY. DUE TO THE DEGREE OF NECK ANGULATION, THE POSSIBLITY OF ENDOVASCULAR REPAIR WAS RULED OUT, AND THE DECISION WAS MADE TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR. FOUR MONTHS LATER, STENT GRAFT WAS EXPLANTED AND THE PT WAS CONVERTED TO OPEN SURGICAL REPAIR. DURING THE PROCEDURE, THE REMOVAL OF THE LEFT ILIAC CLIMB CAUSED AN INTIMAL ENDARTERECTOMY BECAUSE IT WAS SO WELL INCORPORATED. POOR BLOOD FLOW NECESSITATED AN IMMEDIATE EMBOLECTOMY. THE FOLLOWING DAY, THE PATIENT HAS NO BLOOD FLOW IN THE LEFT LEG WITH APPARENT ISCHEMIA. A RIGHT FEMORAL ARTERY TO LEFT FEMORAL ARTERY BYPASS WAS PEROFRMED. THE PATIENT WAS DISCHARGED 8 DAYS LATER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS REPORTED TO BE FINE. THE EXPLANTED STENT GRAFT HAS BEEN RECEIVED BY MEDTRONIC AVE, AND ITS ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIX ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M9811155

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention