BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 13567457 · Received February 21, 2022

    Report

    Report Number
    3002808486-2022-00132
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    February 1, 2022
    Report Date
    May 9, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). (B)(4) IS TO BE CLOSE/CANCEL AS IT IS ASSESSED TO BE A SIDE EFFECT AND IS RELATED TO PROCEDURE. THE EVENT WILL BE HANDLE IN (B)(4) (MANUFACTURER REF# 3002808486-2022-00130) . THEREFORE THIS COMPLAINT WILL BE CLOSED/CANCELLED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PATIENT WHO HAD A ENDOVASCULAR THORACO/ABDOMAL ANEURSYM REPAIR WITH THORACIC STENTING DEVELOPED PARAPLEGIA ABOUT 3 HOURS AFTER THE PROCEDURE WAS COMPLETED. SHE HAD A SPINAL DRAIN INSERTED EARLY THIS AM, BUT REMAINS PARALYZED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330835 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female