BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1051121 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00344
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: (NO DEVICE RETURNED FOR EVAL).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THERE WAS PERSISTENT TYPE 2 ENDOLEAK WHICH LED TO ENLARGEMENT OF THE AORTIC NECK AND ENCROACHMENT. THE DECISION WAS MADE TO SURGICALLY CONVERT THE PT AND THE STENT GRAFTS WERE EXPLANTED. THE ANEURYSM HAD SEVERAL AREAS OF REMARKABLE THINNING, AND IT WAS 8 CM IN DIAMETER. THE AORTIC NECK BELOW THE RENAL ARTERIES WAS ANGULATED AND SHORT. THE STENT GRAFTS CAME OUT EASILY AND A TYPE 1 ENDOLEAK HAD BEEN PRESENT. THERE WAS EVIDENCE OF PREVIOUS COILING OF THE MIDDLE SACRAL ARTERY. SEVERAL SMALLER LUMBAR ARTERIES WERE BACK BLEEDING AND THEY WERE OVERSEWN. THE ANEURYSM WALL WAS TRIMMED AND A PROXIMAL ANASTAMOSIS WAS CARRIED OUT WITH A HEMASHIELD GRAFT. THE STENT GRAFTS WERE AMPUTATED AT THE LEVEL OF THE COMMON ILIAC ARTERIES. THERE WERE STRONG PULSES NOTED IN BOTH ILIAC AND FEMORAL VESSELS. THE ANEURYSM WAS CLOSED. THE PT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE EXPLANTED STENT GRAFTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M9975614

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention