BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 2234286 · Received August 29, 2011

    Report

    Report Number
    2953200-2011-01488
    Event Type
    Death
    Date Received
    August 29, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH, RUPTURED ANEURYSM/VESSEL), (SEVERELY FRAIL AND THIN AORTIC WALLS), (BALLOON OUTSIDE THE STENT GRAFT). EVAL, CONCLUSIONS: (SEVERELY FRAIL AND THIN AORTIC WALLS), (BALLOON OUTSIDE THE STENT GRAFT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 8 MM IN LENGTH AND 21 MM TO 30 MM IN DIAMETER. ILIAC ARTERIES HAD MILD CALCIFICATION AND MODERATE TORTUOSITY. IT WAS REPORTED THAT AFTER THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED, A DISTAL TYPE I ENDOLEAK WAS EVIDENT (MFR REPORT # 2953200-2011-01486). THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING AN ILIAC EXTENSION LIMB (MFR REPORT # 2953200-2011-01487). THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFTS WITH A RELIANT BALLOON (MFR REPORT # 2953200-2011-01488); HOWEVER, WHEN MODELING THE LEFT ILIAC ARTERY, THE BALLOON WAS NOT COMPLETELY WITHIN THE STENT GRAFT, BUT NO ISSUES WERE NOTED AT THAT TIME. AT SOME POINT DURING THE PROCEDURE, THE ANEURYSM SAC RUPTURED. THE PHYSICIAN ELECTED TO INTERVENE BY CONVERTING THE PT TO AN OPEN REPAIR. DURING THE OPEN REPAIR, THE PHYSICIAN NOTED THAT THE PT HAD SEVERLY FRAIL AND THIN AORTIC WALLS. THE PHYSICIAN COULD NOT CONTROL THE BLEEDING DUE TO THE FRAIL VESSELS, AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY MEDTRONIC CARDIOVASCULAR SANTA ROSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R