BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2181215 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01329
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ARTERIAL DISSECTION), (MODERATE/SEVERE CALCIUM IN THE VESSELS). CONCLUSION: (MODERATE/SEVERE CALCIUM IN THE VESSELS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MODERATE/SEVERE CALCIUM IN THE VESSELS; THE AORTIC NECK MEASURED 24 MM IN LENGTH AND IT WAS 25 MM IN DIAMETER PROXIMALLY AND DISTALLY AND 26 MM IN THE MID SECTION. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS ADVANCED FROM THE RIGHT SIDE WITH SOME RESISTANCE AND DEPLOYED TO THE LEVEL OF THE CONTRALATERAL GATE. THE PHYSICIAN CANNULATED THE CONTRALATERAL GATE, DEPLOYED THE CONTRALATERAL LIMB AND REMOVED THE CONTRALATERAL LIMB DELIVERY SYSTEM. THE PHYSICIAN THEN DEPLOYED THE REMAINDER OF THE BIFURCATED STENT GRAFT AND RECAPTURED SPINDLE/TIP AND REMOVED THE DELIVERY SYSTEM. THERE WAS THEN A DECLINE IN BLOOD PRESSURE. THE PHYSICIAN PLACED A RELIANT BALLOON. RETROGRADE FILMS SHOWED A RIGHT DISSECTION/RUPTURE BUT DID NOT SHOW EXACTLY WHERE THE TEAR WAS LOCATED AT. THE PHYSICIAN THEN EXTENDED DOWN WITH ENDURANT 13X13X82 AND 10X10X82 DEVICES. THE PHYSICIAN DID NOT PLAN TO COVER THE HYPOGASTRIC ARTERY. RETROGRADE FILMS SHOWED A RUPTURE AT THE COMMON FEMORAL/EXTERNAL ILIAC JUNCTION. THE PHYSICIAN THEN IMPLANTED A DEVICE WHICH EXTENDS DOWN PAST THE INGUINAL LIGAMENT INTO THE COMMON FEMORAL ARTERY. RETROGRADE FILMS THEN SHOWED THE RUPTURE TO BE COVERED AND STABLE. THE PHYSICIAN THEN BALLOONED THE GRAFT. THE PHYSICIAN ASSESSED THAT THE RUPTURE OCCURRED AT AN UNUSUAL PLACE. THE PATIENT IS DOING WELL. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00877369

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention