BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2234109 · Received August 30, 2011

    Report

    Report Number
    1820334-2011-00473
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 4, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO CONSEQUENCES TO THE PT WERE REPORTED. (B)(4) ENDOLEAKS ARE LABELED IN THE 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. FINAL ANGIO REVEALED A TYPE IA ENDOLEAK. PLACEMENT OF A STENT REDUCED THE ENDOLEAK AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. IT WAS EXPECTED THAT THE ENDOLEAKS WOULD RESOLVE AFTER HEPARIN NEUTRALIZATION. IT IS DIFFICULT TO DETERMINE THE CAUSE OF THE ENDOLEAK WITHOUT IMAGING AND ANATOMICAL DETERMINANTS. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. AT THIS TIME THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTS IN THE REPORTED ENDOLEAK. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR UNDER GENERAL ANESTHESIA ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR ALTHOUGH BOTH SIDE OF ACCESS VESSELS WERE PARTIALLY STENOSED (THE DIAMETER WAS PARTIALLY 3MM AND 4MM) AND CALCIFICATION WAS ALSO OBSERVED. MOREOVER, THE PT'S ANAMNESIS WAS KIDNEY DISEASE, ISCHEMIC HEART DISEASE AND HYPERPIESIA. PTA AND DILATION WITH A DILATOR WERE PERFORMED FOR STENOSED VESSEL. AFTER STENT GRAFT PLACEMENT, FINAL ANGIOGRAPHY REVEALED PROXIMAL TYPE I ENDOLEAK. BALLOONING WAS PERFORMED WITH A CODA BALLOON AND THE ENDOLEAK WAS REDUCED. ANOTHER BALLOONING WAS MADE, BUT THE ENDOLEAK WAS NOT COMPLETELY RESOLVED. THEN ANOTHER MANUFACTURER'S STENT MOUNTED ON A PTA CATHETER WAS PLACED. THE ENDOLEAK WAS REDUCED BUT STILL REMAINED. TYPE II ENDOLEAK WAS ALSO OBSERVED, BUT THE PHYSICIAN DECIDED TO TAKE FOLLOW-UP OBSERVATION SINCE HE THOUGHT BOTH OF THE ENDOLEAK WOULD BE RESOLVED AFTER HEPARIN NEUTRALIZATION. NO ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2643481

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention