BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6371112 · Received March 2, 2017

    Report

    Report Number
    3002808486-2017-00679
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    September 17, 2014
    Report Date
    January 29, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527185
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: ZTEG-2PT-42-158-PF. SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE FAILURE MODE ASSIGNED TO THIS CASE IS REMOVAL/LOSS OF HC. BY REPORT THE PATIENT DEVELOPED A RASH 5 DAYS AFTER A ZENITH ENDOVASCULAR PROCEDURE. ADDITIONAL TREATMENT WAS OBTAINED VIA A DERMATOLOGIST AND A BIOPSY WAS PERFORMED. NO PRODUCT OR IMAGING WERE RETURNED TO ASSIST WITH THIS INVESTIGATION, AND LIMITED INFORMATION WAS PROVIDED. INTERNAL ACTIONS ADDRESSED TO THE REMOVAL/LOSS OF HC COATING ON ZENITH PRODUCTS. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2014: A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT TAA REPAIR WITH RIGHT APPROACH WITH ZTEG-2PT-42-158-PF ((B)(4)) AND TBE-42-81-JP ((B)(4)). CALCIFICATION AND TORTUOSITY WERE OBSERVED IN THE CIA, BUT THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR THE PROCEDURE. SLIGHT RESISTANCE WAS ENCOUNTERED WHEN THESE DELIVERY SYSTEMS WERE ADVANCED THROUGH THE ACCESS ROUTE DUE TO CALCIFICATION. HOWEVER, THE WHOLE PROCEDURE INCLUDING POSITIONING OF THE STENT GRAFTS WENT WELL AND WAS COMPLETED WITH NO PROBLEM. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014: MILD SKIN PROBLEMS WERE OBSERVED IN THE RIGHT LOWER EXTREMITY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014: THE PATIENT SAW A DERMATOLOGIST DUE TO NO IMPROVEMENT OF THE RASH. BIOPSY WAS PERFORMED NEAR THE CIA SINCE EMBOLIZATION OF FOREIGN MATERIAL WAS SUSPECTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014: THE EXAMINATION OF THE TISSUE UNDER A MICROSCOPE CONFIRMED FIBROUS MATERIAL, SO THE SYMPTOM WAS DIAGNOSED WITH EMBOLIZATION OF FOREIGN MATERIAL. WITH THE INSPECTION RESULT AND POSITIONS OF THE ACCESS VESSEL AND THE RASH, THE PHYSICIAN ASSUMED THAT COATING MATERIAL OF THE TX2 DELIVERY SYSTEMS WAS REMOVED DURING ADVANCEMENT DUE TO TORTUOSITY AND CALCIFICATION, WHICH EVENTUALLY SPREAD IN THE VESSEL AND CAUSED EMBOLISM. (*IT IS STILL POSSIBLE THAT COATING MATERIAL OF ANOTHER USED DEVICE, RADIFOCUS/ BY TERUMO, WAS RELATED TO THE EVENT.) ADDITIONAL INFORMATION RECEIVED (B)(6) 2014: THE RASH ALMOST DISAPPEARED WITH NO TREATMENT. NO ADDITIONAL TREATMENT HAS BEEN CONDUCTED. PATIENT OUTCOME: NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156619 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527185

    Patients

    Seq Age Sex Outcome Treatment
    1 79 Life Threatening