BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2152984 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01196
    Event Type
    Death
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH, AORTIC VESSEL RUPTURE, CONVERSION TO SURGICAL REPAIR), (CONICAL AORTIC NECK; SIGNIFICANT THROMBUS; IRREGULAR-SHAPED DISTAL AORTA), (UNK CAUSE OF REMOVAL DIFFICULTIES). CONCLUSIONS: (CONICAL AORTIC NECK; SIGNIFICANT THROMBUS; IRREGULAR-SHAPED DISTAL AORTA), (UNK CAUSE OF REMOVAL DIFFICULTIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM X 5.2 CM ABDOMINAL AORTIC ANEURYSM. THE PT HAS A HISTORY OF HAVING A LUNG REMOVED DUE TO CANCER. THE AORTIC NECK WAS CONICAL IN SHAPE, 21 MM IN DIAMETER AT THE RENALS AND 26 MM IN DIAMETER ABOVE THE ANEURYSM, AND 20 MM LONG WITH MILD CALCIFICATION AND MILD ANGULATION. THE ILIACS WERE 11 MM IN DIAMETER. IT WAS REPORTED THAT AN ENDURANT BIFURCATED STENT GRAFT (MFR REPORT #2953200-2011-01196) WAS IMPLANTED VIA THE RIGHT SIDE, FOLLOWED BY IMPLANTING AN ENDURANT 16X13X93 CONTRALATERAL LIMB (MFR REPORT # 2953200-2011-01197) AND THEN PLACING AN ENDURANT 13X13X82 CONTRALATERAL ILIAC EXTENSION (MFR REPORT # 2953200-2011-01198) TO EXTEND TO THE LEVEL OF THE LEFT HYPOGASTRIC ARTERY. WHEN ATTEMPTING TO RECAPTURE THE TIP OF THE ENDURANT BIFURCATED DELIVERY SYSTEM, THE DELIVERY SYSTEM BECAME CAUGHT IN THE BODY OF THE BIFURCATED STENT GRAFT. THE PHYSICIAN ADVANCED AND ROTATED AND THE DELIVERY SYSTEM, WHICH FREED THE DELIVERY SYSTEM; THE TIP WAS RECAPTURED, AND THE DELIVERY SYSTEM WAS REMOVED. UPON REMOVAL OF THE DELIVERY SYSTEM, THE WIRE GOT CAUGHT IN THE DELIVERY SYSTEM, AND WIRE ACCESS WAS LOST. AT THIS POINT, THE PT'S BLOOD PRESSURE BEGAN TO DROP. A RELIANT BALLOON WAS ADVANCED ON THE CONTRALATERAL SIDE AND WAS INFLATED AT THE LEVEL OF THE PROXIMAL STENT GRAFT. A SECOND RELIANT BALLOON WAS ADVANCED ON THE IPSILATERAL SIDE AND INFLATED. HOWEVER, EVEN WITH THE AORTA OCCLUDED, THE PT'S BLOOD PRESSURE CONTINUED TO DROP. AT THIS TIME, THE RELIANT BALLOON WAS REMOVED ON THE LEFT SIDE, AND A SECOND ENDURANT BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2011-01199) WAS ADVANCED AND DEPLOYED. THE PT'S BLOOD PRESSURE DID NOT RECOVER, AND THE SURGEON ELECTED TO PROCEED TO AN OPEN SURGICAL REPAIR. HOWEVER, THE PT EXPIRED DURING THE ATTEMPTED OPEN SURGICAL REPAIR. IT WAS REPORTED THAT THERE WAS MOST LIKELY A DISTAL AORTIC RUPTURE, WHICH WAS NOT APPARENT DURING THE CASE AND MAY HAVE OCCURRED DURING THE MANIPULATION OF THE STENT GRAFT WHILE ATTEMPTING TO FREE THE DELIVERY SYSTEM. PRE-IMPLANT FILMS WERE REVIEWED INTERNALLY AND SHOWED SIGNIFICANT THROMBUS WITHIN THE ANEURYSM. THE DISTAL AORTA IS IRREGULAR IN SHAPE. THE CAUSE OF THE AORTIC PERFORATION/RUPTURE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00849750

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R