BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6309879 · Received February 8, 2017

    Report

    Report Number
    3002808486-2017-00335
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 23, 2015
    Report Date
    January 23, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527031
    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)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INFORMATION AVAILABLE, IT IS PLAUSIBLE THAT THE PROBLEMS WITH A GAB BETWEEN DILATOR TIP AND SHEATH CONTRIBUTED TO THE ADVANCEMENT DIFFICULTIES. HOWEVER SINCE PRODUCT WAS NOT RETURNED IT IS NOT POSSIBLE TO DETERMINE IF THE ADVANCEMENT DIFFICULTIES WAS CAUSED SOLELY BY THE GAB. ADDITIONALLY ADVANCEMENT DIFFICULTIES COULD ALSO BE RELATED TO PATIENT SELECTION SINCE THE "DIAMETER OF THE ACCESS ROUTE WAS 8.2 MM (...), THE DELIVERY SYSTEM WAS INSERTED FROM THE CONTRALATERAL SIDE THOUGH, IT WOULD NOT ADVANCE DUE TO CALCIFICATION". COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: AN (B)(6) MALE PATIENT UNDERWENT TAA REPAIR WITH RIGHT APPROACH ON (B)(6) 2015. DIAMETER OF THE ACCESS ROUTE WAS 8.2 MM WHICH SOUNDED SLIGHTLY SMALL COMPARED WITH OUTER DIAMETER OF THE DEVICE 8.5 MM. HOWEVER BECAUSE CONDITIONS OF THE VESSEL WAS NOT BAD WITHOUT CALCIFICATION, THE PHYSICIAN JUDGED THAT THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. PRIOR TO INSERTING THE DELIVERY SYSTEM OF THE TX2 INTO THE PATIENT, DISSECTION OCCURRED IN THE ACCESS ROUTE PROBABLY WHEN THE PUNCTURE SITE WAS INCISED. THEREFORE, GORE'S EXCLUDER 12 MM WAS PLACED IN THE DISSECTED ACCESS ROUTE. ALSO, A WIRE GUIDE (RADIFOCUS/ BY (B)(4)) SUBSEQUENTLY ADVANCED BEFORE NOTICING THE DISSECTION MIGHT HAVE BEEN ADVANCED INTO THE FALSE LUMEN, WHICH COULD HAVE CAUSED THE DISSECTION OF THE ABDOMINAL AORTA. THE PHYSICIAN EXPECTED THAT THE DELIVERY SYSTEM OF THE TX2 WOULD BE ABLE TO PASS THROUGH THE EXCLUDER WITH NO PROBLEM SINCE THE INNER DIAMETER OF THE EXCLUDER WAS 12 MM. HOWEVER, A GAP BETWEEN THE DILATOR TIP AND SHEATH WAS CAUGHT ON THE EXCLUDER. THEN, BALLOONING WITH A PTA BALLOON WAS PERFORMED INSIDE THE EXCLUDER LEG. THE DELIVERY SYSTEM WAS REINSERTED, BUT THE GAP WAS CAUGHT AGAIN. THEN, THE DELIVERY SYSTEM WAS INSERTED FROM THE CONTRALATERAL SIDE THOUGH, IT WOULD NOT ADVANCE DUE TO CALCIFICATION OBSERVED PRIOR TO THE PROCEDURE. ALTHOUGH APPROACH BY OPENING THE ABDOMEN WAS CONSIDERED, THE PROCEDURE WAS FINISHED WITH NO ADDITIONAL TREATMENT ON THE DAY IN CONSIDERATION OF POSSIBLE DISSECTION OF THE ABDOMINAL AORTA WHICH MIGHT HAVE OCCURRED DURING ADVANCEMENT OF RADIFOCUS. TEVAR IS PLANNED TO BE CONDUCTED ON THE OTHER DAY. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94785 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527031

    Patients

    Seq Age Sex Outcome Treatment
    1 83 Required Intervention