BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 12653538 · Received October 19, 2021

    Report

    Report Number
    3002808486-2021-01888
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    May 9, 2020
    Report Date
    November 19, 2021
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002355238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). ADDITIONAL INFORMATION RECEIVED IN DESCRIPTION OF EVENT INDICATES THAT THE ALPHA DEVICE WAS NOT INVOLVED IN THE EVENT. IT DOES NOT MEET THE REQUIREMENTS STATED UNDER 21 CFR PART 803.20. THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. 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

    ADDITIONAL INFORMATION RECEIVED 27OCT2021: RECEIVED THE CT SCAN. THE PHYSICIAN REVIEWED THE IMAGES AND IT APPEARS THAT THE COMPONENT SEPARATION WAS BETWEEN THE CMD AND BIFURCATED DEVICE. ALPHA PORTION LOOKED INTACT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. ON (B)(6) 2020: ENDOVASCULAR REPAIR OF RUPTURED AAA WITH ENDOVASCULAR GRAFTS; ON (B)(6) 2020: TYPE III ENDOLEAK REPAIR OF 2 AORTIC CUFFS. NO DETAILED INFORMATION IS AVAILABLE AS THESE PROCEDURES WERE PERFORMED AT OUTSIDE FACILITY. PATIENT OUTCOME: NO INFORMATION REGARDING THE PATIENT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555961 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G35523 E3431552 10827002355238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention