BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6331275 · Received February 15, 2017

    Report

    Report Number
    3002808486-2017-00421
    Event Type
    Injury
    Date Received
    February 15, 2017
    Report Date
    August 29, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    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)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION PROVIDED IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER THERE IS NO EVIDENCE TO SUGGEST DEVICE FAILURE. THIS IS SUPPORTED BY THE PHYSICIANS COMMENT "IT WAS NOT DUE TO THE DEVICE" IT IS POSSIBLE THAT THE PATIENT CONDITION CONTRIBUTED TO THE OCCURRENCE. IF THE ACCESS VESSELS ARE CALCIFIED ADVANCEMENT DIFFICULTIES CAN OCCUR AND SINCE THE PHYSICIAN WAS ABLE TO ADVANCE A DEVICE WITH A SMALLER FR. SIZE THIS MAY HAVE BEEN THE CAUSE FOR THIS EVENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION PROVIDED IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER THERE IS NO EVIDENCE TO SUGGEST DEVICE FAILURE. THIS IS SUPPORTED BY THE PHYSICIANS COMMENT "IT WAS NOT DUE TO THE DEVICE" IT IS POSSIBLE THAT THE PATIENT CONDITION CONTRIBUTED TO THE OCCURRENCE. IF THE ACCESS VESSELS ARE CALCIFIED ADVANCEMENT DIFFICULTIES CAN OCCUR AND SINCE THE PHYSICIAN WAS ABLE TO ADVANCE A DEVICE WITH A SMALLER FR. SIZE THIS MAY HAVE BEEN THE CAUSE FOR THIS EVENT. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN SELECTED A ZTEG-2PT-32-160-PF FOR AN (B)(6) YEAR OLD FEMALE PATIENT WITH TAAA. THE PATIENT'S EXTERNAL ILIAC ARTERY WAS 6-7 MM, BUT HE DETERMINED THE DEVICE COULD BE ADVANCED SINCE NO CALCIFICATION AND TORTUOUS ANATOMY WAS CONFIRMED. HE INSERTED THE DELIVERY SYSTEM FROM THE COMMON FEMORAL ARETERY, HOWEVER THE INSERTION WAS DIFFICULT DUE TO CALCIFICATION IN THE INSERTION SITE. HE MADE A INCISION IN THE UPPER AREA AND SUCCEEDED IN INSERTION. AFTER PLACEMENT OF THE STENT GRAFT, A PARTIAL DISSECTION IN THE VESSEL WAS CONFIRMED AND REPLACED THE SITE WITH AN ARTIFICIAL VESSEL, AND COMPLETED THE PROCEDURE. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113984 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening