BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1901501 · Received November 12, 2010

    Report

    Report Number
    1820334-2010-00559
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNK AS LOT IS UNK. ACTUAL DATE OF EXPLANT IS UNK. (B)(4). MANUFACTURE DATE: UNK AS LOT IS UNK. EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS AGO, A FEMALE, PT, UNDERWENT AAA REPAIR AND RECEIVED ONE MAIN BODY AND TWO ILIAC LEGS AT ANOTHER MEDICAL FACILITY. ON (B)(6) 2010, THE PT CLAIMED ABDOMINAL PAINS AND WAS TRANSFERRED TO A RELATED MEDICAL FACILITY SINCE ABDOMINAL AORTIC ANEURYSM WAS SUSPECTED TO BE RUPTURED. THEN PT WAS TRANSFERRED TO THE REPORTING FACILITY. THE MAIN BODY GRAFT IMPLANTED THREE YEARS AGO WAS CUT AND REMAINED ONLY PROXIMAL AND DISTAL PART. THE MIDDLE PORTION WAS REMOVED AND AN ARTIFICIAL BLOOD VESSEL WAS SUTURED TO THE REMAINING PART. FOLLOWING IS THE PHYSICIAN'S STATEMENT. THE PT VISITED THE ORIGINAL HOSPITAL TWO WEEKS AGO, BUT NO SYMPTOM WAS OBSERVED AT THAT TIME. ACCORDING TO THE IMAGE THAT WAS TAKEN WHEN THE PT WAS TRANSFERRED TO US, PROXIMAL TYPE I ENDOLEAK AND TYPE II ENDOLEAK WERE SUSPECTED, BUT IT WAS DIFFICULT TO DETERMINE IT. ANEURYSM WAS THOUGHT TO BE INTERNALLY-PRESSURIZED SINCE THE DIAMETER OF IT WAS MORE THAN 80MM. THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention