BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN B

    MDR report key: 1900171 · Received November 10, 2010

    Report

    Report Number
    1820334-2010-00587
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK AS NOT PROVIDED BY REPORTER. EXPIRATION - UNK AS LOT IS UNK. (B)(4). MANUFACTURE DATE: UNK AS LOT IS UNK. 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, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. WITHOUT ANATOMICAL DETERMINANTS OR IMAGING, WE ARE UNABLE TO COMMENT ON THE PT'S SUITABILITY FOR EVAR. A TYPE 1A ENDOLEAK DEVELOPED AFTER INITIAL REPAIR. THE ENDOLEAK WAS TREATED WITH A ZENITH MAIN BODY EXTENSION. THE AORTA RUPTURED DURING BALLOONING. THE PT WAS CONVERTED TO OPEN REPAIR AND TOLERATED THE PROCEDURE. PT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAK AND RUPTURE. THE COMPLAINT CORRESPONDENCE INDICATED THAT THE PT'S AORTA WAS FRAIL, PROLONGING OPEN REPAIR. (B)(4) CLINICAL REVIEW DETERMINED IATROGENIC RUPTURE DURING BALLOONING. THERE IS NO EVIDENCE TO SUGGEST AT THIS TIME THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE COMPLAINT DEVICE RESULTED IN THE ENDOLEAK OR SUBSEQUENT EVENTS DURING INTERVENTION. THE EVENT WILL BE TRENDED AS SERIOUS HARM (OPEN REPAIR). 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) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH THE INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2010. THE PHYSICIAN PERFORMED A REGULAR AAA EVAR, AND UPON COMPLETION, A TYPE I ENDOLEAK WAS NOTED. THE PHYSICIAN PLACED A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION AND REBALLOONED. IMAGING SHOWED A PARTIAL RUPTURE THAT WAS CONFIRMED BY A DROP IN BLOOD PRESSURE WHICH ANESTHESIA INFORMED THOSE INVOLVED AFTER THE PLACEMENT AND BALLOONING OF THE CUFF. BECAUSE OF WHERE THEY ASSUMED THE RUPTURE TO BE (POSTERIOR DIRECTLY AT THE RENAL ARTERIES), THE ONLY OPTION WAS TO FIX IT VIA OPEN REPAIR. THE PT WAS CONVERTED TO OPEN REPAIR AND THE PHYSICIAN LEFT THE MAIN BODY AND BOTH ILIAC LIMBS IN THE PT. HE REMOVED THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION AND REMOVED THE SUPRARENAL STRUTS FROM THE ZENITH BIFURCATED MAIN BODY. THEY SEWED AN OPEN TUBE GRAFT ON THE VESSEL AND THE IMPLANTED ZENITH ENDOGRAFT. IT TOOK MULTIPLE ATTEMPTS AT SEWING THE OPEN GRAFT ONTO THE PT'S AORTA, AS THE AORTA WAS VERY THIN WALLED AND FELL APART OFTEN. IT EVENTUALLY TOOK AND THE RUPTURE WAS FIXED, PT DOING WELL. THE PT CONVERTED TO OPEN REPAIR WHERE THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS REMOVED AS WELL AS THE SUPRARENAL STRUT FROM THE ZENITH BIFURCATED MAIN BODY. THE CONVERSION TO OPEN REPAIR WAS SUCCESSFUL AND IT HAS BEEN REPORTED THAT THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN B MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention