BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6338531 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00483
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    July 16, 2013
    Report Date
    July 16, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)($). SUMMARY OF INVESTIGATIONAL FINDINGS: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO IMAGES WERE PROVIDED. THE ADVANCEMENT DIFFICULTIES COULD HAVE BEEN CAUSED BY PATIENT ANATOMY HOWEVER, AS NO PRODUCT, PHOTOS OR IMAGING WAS RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. NOTHING INDICATES DEVICE FAILURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO IMAGES WERE PROVIDED. THE ADVANCEMENT DIFFICULTIES COULD HAVE BEEN CAUSED BY PATIENT ANATOMY HOWEVER, AS NO PRODUCT, PHOTOS OR IMAGING WAS RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. NOTHING INDICATES DEVICE FAILURE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN PLANNED TO PLACE TWO ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENTS TO RIGHT ABOVE THE CELIAC ARTERY FROM THE DISTAL ANASTOMOTIC SITE OF THE PREVIOUSLY PLACED ARTIFICIAL VESSEL. THE DEVICE WAS INSERTED FROM THE RIGHT WITH PULL-THROUGH TECHNIQUE. THE FIRST ONE WAS ADVANCED AND PLACED WITHOUT PROBLEM, BUT THE SECOND ONE WOULD NOT ADVANCE ANY FURTHER THAN THE AORTA ARCH. IF HE DEPLOYED THE STENT GRAFT THERE, IT WOULD COVER THE CELIAC ARTERY, SO HE REPLACED IT WITH THE DIFFERENT SIZE (140CM) AND ITS DILATOR ALSO DIDN'T PASS THE AORTA ARCH, BUT THE STENT GRAFT WAS PLACED WITHOUT COVERING THE CELIAC ARTERY. THE PHYSICIAN PLACED AN ESBE-28-80-T-JP AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121310 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526768

    Patients

    Seq Age Sex Outcome Treatment
    1