BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2946201 · Received January 4, 2013

    Report

    Report Number
    1820334-2013-00025
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 13, 2012
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES TO THE PATIENT WERE REPORTED. DIFFICULT DEPLOYMENT IS LISTED IN THE INSTRUCTIONS FOR USE. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. CONTROLS ARE IN PLACE FOR THE SOLDERING PROCESS ENSURING THE BARBS, ON THE SUPRARENAL STENT, HAVE THE CORRECT AMOUNT OF SOLDER AND CORRECT AMOUNT OF SPACING BETWEEN THE STENT STRUTS AND BARB WIRE. THE INFORMATION AVAILABLE IN THE COMPLAINT FILE, THE DEVICE INSTRUCTIONS FOR USE, APPLICABLE QUALITY ENGINEERING RISK ANALYSIS, AND COMPLAINT HISTORY WERE REVIEWED AS PART OF THE INVESTIGATION. IT WAS CONCLUDED THAT THE FAILURE MODE IN THIS CASE WAS DIFFICULT TO RELEASE, AS A RESULT OF A DIFFICULT TO REMOVE TOP CAP DURING THE PROCEDURE. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION IN THIS CASE, AND SIMILARITIES WITH OTHER EVENT DESCRIPTIONS WITH THIS FAILURE MODE. RISK ANALYSIS WAS USED TO EVALUATE RISK. THE EVENT WAS TRENDED AS LOW IMPACT TO THE PATIENT. THIS COMPLAINT FALLS UNDER THE SCOPE OF A CAPA. VERY LITTLE INFORMATION WAS PROVIDED TO ASSIST WITH THIS INVESTIGATION. HOWEVER, IT APPEARS THAT THE USER COMPLETED SOMETHING SIMILAR TO THE ALTERNATIVE DEPLOYMENT SEQUENCE, AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCE TO THE PATIENT (LOW IMPACT). WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND NOTIFY THE APPROPRIATE INTERNAL PERSONNEL.

    Description of Event or Problem · 1

    THE ISSUE WAS THAT THE TOP CAP WOULD NOT COME OFF (36 MM GRAFT) - DR ENDED UP ADVANCING THE CENTRAL STIFFENER AFTER RELEASING EVERYTHING AND IT CAME OFF EVENTUALLY. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5568 ZENITH FLEX 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