BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2231221 · Received July 25, 2011

    Report

    Report Number
    1820334-2011-00438
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION AND CLINICAL REVIEW DETERMINED ON (B)(4) 2011 THAT THIS EVENT IS REPORTABLE. STENT SIZE IS INCORRECT IS NOT LABELED IN THE IFU. EVALUATION: EVENT STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE OUTER PACKAGING WAS OPENED AND CHECK FOR STENT SIZE. INNER PACKAGE WAS CHECKED AND OPENED, STERILE CONTENTS TAKEN AND PREPARED AS NORMAL. THE STENT WAS PLACED INSIDE THE PATIENT. UNDER FLUOROSCOPY STENT WAS TOO LONG. REP COUNTED THE STENTS AND KNEW BY THE NUMBER OF STENTS ON THE GRAFT THE STENT WAS THE WRONG SIZE. PATIENT OUTCOME IS UNKNOWN AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2702751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK