BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1941035 · Received December 8, 2010

    Report

    Report Number
    1820334-2010-00639
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 12, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) - ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE 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. 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 (B)(4) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE EVENT WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PHYSICIAN PERFORMED THE PROCEDURE AS LABELED. THE PHYSICIAN DID ANGIOGRAPHY AND RECOGNIZED THE DISTAL TYPE I ENDOLEAK. THEN THE PHYSICIAN TRIED TO RESOLVE THE ENDOLEAK, BUT IT COULD NOT BE RESOLVED. (DID ANGIOGRAPHY IN THE MAIN BODY AND BALLOONING AGAIN AT THE CONNECTING PORTION OF THE STENT). FINALLY, THE PHYSICIAN DECIDED THAT THE ENDOLEAK IS TYPE IV. THE PT WAS KEPT UNDER OBSERVATION. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010. THE TYPE IV ENDOLEAK WAS RESOLVED AND THE PT WAS RELEASED FROM HOSPITAL (RELEASED DATE IS UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2563573

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR