BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6344880 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00546
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA 510(K): SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INSPECTION OF THE RETURNED PRODUCT AND INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER THE FOLLOWING CAUSES ARE LIKELY: ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE EXPOSURE OF THE PROXIMAL BARE STENTS WHILST INTRODUCING THE DELIVERY SYSTEM TO THE PATIENT. WITHDRAWAL OF SHEATH TOWARDS HANDLE WHILE HANDLING THE GRAFT SYSTEM, PRIOR TO INTRODUCTION INTO PATIENT, COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE EXPOSURE OF THE PROXIMAL BARE STENTS. NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILST INTRODUCING OUR DEVICE THE SHEATH WITHDREW AND EXPOSED PROXIMAL BARE STENTS. RE-SHEATHING WAS ATTEMPTED, HOWEVER UNSUCCESSFUL. PROCEDURE WAS STOPPED. PATIENT OUTCOME: PATIENT WILL NEED TO BE READMITTED TO COMPLETE REPAIR. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128650 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346984

    Patients

    Seq Age Sex Outcome Treatment
    1