BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1924552 · Received December 7, 2010

    Report

    Report Number
    2953200-2010-02432
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    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

    (B)(4). EVAL, RESULTS: MIGRATION; DISEASE PROGRESSION AND DILATED AORTIC NECK, ECTATIC ILIAC ARTERY; STENT GRAFT WAS USED TO TREAT A PRE-OPERATIVELY RUPTURED ANEURYSM. EVAL, CONCLUSION: DISEASE PROGRESSION AND DILATED AORTIC NECK, ECTATIC ILIAC ARTERY; STENT GRAFT WAS USED TO TREAT A PRE-OPERATIVELY RUPTURED ANEURYSM.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF A 4.4 CM RUPTURED ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 8 YEARS AGO. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. IT WAS REPORTED THAT THERE WAS A SPACE OF 2 CM BETWEEN THE RENALS AND THE TOP OF THE BIFURCATED STENT GRAFT WITH EVIDENCE OF NECK DILATATION FOUND; HOWEVER, THERE WAS NO ENDOLEAK. A CT ANGIO OF THE ABDOMEN AND PELVIS FROM 3 MONTHS AGO SHOWED THERE WAS NO STENT GRAFT MIGRATION AND NO ENDOLEAK. CURRENTLY, THE ANEURYSM MEASURES 29 MM IN DIAMETER, THE NECK ANGLE IS 25 DEGREES, IT IS REVERSE FUNNEL SHAPED, IT MEASURED 23 MM AT THE RENALS AND 15 MM DISTALLY IT IS 26 MM. THERE IS 5 CM OF DISTAL FIXATION ON THE LEFT AND 3 CM ON THE RIGHT. THE CAUSE OF MIGRATION WAS ATTRIBUTED TO DISEASE PROGRESSION AND AORTIC NECK DILATATION. AN ILIAC LIMB WAS IMPLANTED TO TREAT A 27 MM ECTATIC ILIAC ARTERY WHICH WAS DISTAL TO THE STENT GRAFT AND AN AORTIC CUFF WAS PLACED AS A PRECAUTIONARY MEASURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M01M750099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention