BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3800262 · Received May 1, 2014

    Report

    Report Number
    1820334-2014-00205
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISSECTION IS LABELED IN THE IFU. EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PT UNDERWENT EVAR ON (B)(6) 2014. THE PHYSICIAN HAD PROBLEMS RETRIEVING THE TOP CAP OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. PHYSICIAN SAYS THAT IT SEEMS LIKE THE MAIN BODY COMPRESSED A LITTLE BIT IF HE TRIED TO MOVE THE SHEATH TOWARD THE TOP CAP. IT WAS NOT POSSIBLE TO MOVE FORWARD WITH THE SHEATH. THE SAFETY KNOB WAS ALREADY LOOSENED AND SET FREE. AFTER A WHILE BY USING A BALLOON AND MOVING THE SHEATH THE PHYSICIAN COULD RETRIEVE THE TOP CAP. AFTER THAT THE PT HAS GOT A DISSECTION TYPE B IN THE THORACIC AORTA. MAYBE BECAUSE OF THE MOVEMENTS OF THE TOP CAP THE PHYSICIAN SAID. ADDITIONAL INFO RECEIVED ON (B)(4) 2014: TWO COOK REPRESENTATIVES SUPPORTED THE CASE, IT WAS NOT POSSIBLE TO MOVE THE SHEATH FORWARD TOWARD THE TOP CAP, MAYBE BECAUSE OF THE KINKING IN THE COMMUNIS AND THE AORTA. AFTER USING A BALLOON TO GET STRAIGHT THE AORTA HE COULD MOVE THE SHEATH TO REACH THE TOP CAP. THE DISTAL FIXATION WAS ALREADY LOOSE. BUT THE PHYSICIAN THINKS IT COULD BE THAT THERE WAS STILL A WIRE IN THE INTRODUCER SYSTEM. AFTER THE CASE, THE PT HAS GOT AN TYPE B DISSECTION IN THE THORACIC AORTA. THE PHYSICIAN THINKS IT COULD HAPPENED DURING THE PROCEDURE BECAUSE OF THE MOVING OF THE TOP CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260976 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 4357450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other