BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6371113 · Received March 2, 2017

    Report

    Report Number
    3002808486-2017-00680
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    April 17, 2014
    Report Date
    February 4, 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. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FAILURE MODE ASSIGNED TO THIS CASE IS REMOVAL/LOSS OF HC. BY REPORT THE PATIENT DEVELOPED A RASH AFTER A ZENITH ENDOVASCULAR PROCEDURE AS WELL AS EMBOLIZATION OF A VESSEL AS WELL AS CLAUDICATION. 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) MALE PATIENT UNDERWENT TAA REPAIR WITH ZTEG-2PT-42-158-PF/ (B)(4)+ TBE-42-81-JP/ (B)(4) BY RIGHT APPROACH. ANOTHER DEVICE INVOLVED IN THE PROCEDURE WAS RADIFOCUS/ BY TERUMO. RIGHT AFTER THE PROCEDURE, RASHES WERE OBSERVED ON THE RIGHT LOWER EXTREMITY. THOUGH THESE IMPROVED, OTHER RASHES WERE OBSERVED ON THE RIGHT ABDOMEN AND BOTH RIGHT AND LEFT LOWER EXTREMITIES. ((B)(4)). ADDITIONAL INFORMATION RECEIVED 25APR2014: THE PATIENT SAW A DERMATOLOGIST. BIOPSY WAS PERFORMED SINCE EMBOLIZATION BY BLOOD CLOTS OR CHOLESTEROL CRYSTAL EMBOLISM WAS SUSPECTED. ADDITIONAL INFORMATION RECEIVED 02MAY2014: THE EXAMINATION OF THE TISSUE CONFIRMED A FOREIGN MATTER, 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. ADDITIONAL INFORMATION RECEIVED 09MAY2014: THE RASHES ALMOST DISAPPEARED WITH NO TREATMENT. ADDITIONAL INFORMATION RECEIVED ON OR AFTER 09MAY2014: CLAUDICATION WAS OBSERVED ALTHOUGH IT IS UNCLEAR IF IT WAS CAUSED BY THE EMBOLIZATION OF FOREIGN MATERIAL. ((B)(4)). 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
    156824 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 85 YR Hospitalization| L