BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1963299 · Received January 10, 2011

    Report

    Report Number
    1820334-2011-00010
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLEAKS ARE ADDRESSED IN THE PROVIDED IFU. 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. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, FOLLOW-UP GUIDELINES. EXCESSIVE ANTICOAGULATION DURING THE CASE MAY HAVE CONTRIBUTED TO THE REPORTED ENDOLEAK. IT IS REASONABLE TO SUGGEST THAT A TYPE 4 ENDOLEAK WILL RESOLVE SPONTANEOUSLY, ESPECIALLY AFTER HEPARIN NEUTRALIZATION, BASED ON PREVIOUS COMPLAINTS AND CLINICAL REVIEW. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA).

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PROCEDURE WAS CONDUCTED AS LABELED. THE PHYSICIAN DID ANGIOGRAPHY AND RECOGNIZED THE ENDOLEAK AT THE CONTRALATERAL LEG PORTION. THE PHYSICIAN DID BALLOONING AND PERFORMED ANGIOGRAPHY FROM THE SHEATH. THEN THE PHYSICIAN CONFIRMED THAT THE ENDOLEAK IS TYPE IV. THE PT KEPT UNDER OBSERVATION.

    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 F2587287

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR