BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3163625 · Received June 11, 2013

    Report

    Report Number
    2953200-2013-01104
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: HYPOTENSION. CALCIFICATION OF ACCESS SITE. INSUFFICIENT INFORMATION; CAUSE OF THE SUDDEN DROP IN ARTERIAL PRESSURE IS UNKNOWN. CONCLUSIONS: HYPOTENSION. CALCIFICATION OF ACCESS SITE. INSUFFICIENT INFORMATION; CAUSE OF THE SUDDEN DROP IN ARTERIAL PRESSURE IS UNKNOWN.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE MAXIMUM ANEURYSM DIAMETER WAS 69.8MM. THE PROXIMAL AORTIC NECK WAS 24.3-31.5MM IN DIAMETER, AND 30MM LONG. THE INFRARENAL NECK ANGLE WAS 44 DEGREES. THE RIGHT ILIAC DIAMETERS WERE 10.3-13.9-14.5MM. THE LEFT ILIAC DIAMETERS WERE 14.8-16.4-13MM. THE FEMORAL ARTERIES WERE 9-10MM IN DIAMETER. THERE WAS MILD CALCIFICATION IN THE PROXIMAL AORTIC NECK, AND MODERATE CALCIFICATION IN BOTH ILIAC ARTERIES. IT WAS REPORTED THAT INTRA-OPERATIVELY THE MAIN BODY STENT GRAFT WOULD NOT TRACK THROUGH THE ARTERY. ANOTHER MANUFACTURER¿S SHEATH WAS USED TO DILATE THE ARTERY. THE MAIN BODY WAS THEN SUCCESSFULLY POSITIONED AND PARTIALLY DEPLOYED. WHEN ATTEMPTING TO IMPLANT THE CONTRALATERAL LIMB, THE PATIENT¿S MEAN ARTERIAL PRESSURE SUDDENLY DROPPED TO APPROXIMATELY 40 MMHG. THE PATIENT WAS GIVEN BLOOD, AND THE PRESSURE RETURNED TO NORMAL. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED THE CONTRALATERAL LIMB, FINISHED DEPLOYMENT OF THE IPSILATERAL LIMB, AND IMPLANTED AN IPSILATERAL EXTENSION. TOTAL ESTIMATED BLOOD LOSS DURING THE PROCEDURE WAS 300CC. THE PHYSICIAN STATED THAT THE CAUSE OF THE SUDDEN DROP IN PRESSURE IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263541 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04029816

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention