BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3170729 · Received June 14, 2013

    Report

    Report Number
    2953200-2013-01128
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, METHODS: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION; NECK DILATATION AND SHORT ANGULATED NECK). UNAPPROVED USE OF DEVICE (80 DEGREE NECK ANGULATION). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (MIGRATION, ENDOLEAK) 50 DEVICE FAILURE RELATED TO PATIENT CONDITION (DISEASE PROGRESSION; NECK DILATATION AND SHORT ANGULATED NECK). (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THREE ENDURANT CUFFS WERE IMPLANTED, BUT THE ENDOLEAK DID NOT RESOLVE. THE PATIENT HAS DECLINED FURTHER INTERVENTION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 7 YEARS POST-INDEX PROCEDURE, AN ANEURX 242440 CUFF WAS IMPLANTED TO RESOLVE A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT FOLLOW-UP IMAGING DONE APPROXIMATELY SIX YEARS LATER REVEALED A STENT GRAFT MIGRATION WITH A PROXIMAL TYPE I ENDOLEAK. THE BIFURCATED STENT GRAFT WAS ALSO FOUND TO BE KINKED. A REVIEW OF THE RETURNED FILMS 13 YEARS POST-INDEX PROCEDURE SHOWS A KINK IN THE BIFURCATED STENT GRAFT, AS WELL AS A MIGRATION OF THE ANEURX CUFF. THERE IS A PROXIMAL TYPE I ENDOLEAK. THE PROXIMAL NECK IS ANGULATED AND SHORT. BOTH LIMBS ARE STILL PATENT. THE CAUSE OF THE MIGRATION AND KINK IS LIKELY DUE TO CONTINUED DISEASE PROGRESSION; NECK DILATATION AND ANGULATED NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271046 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 1000063

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention