BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6168969 · Received December 13, 2016

    Report

    Report Number
    3002808486-2016-01490
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR DEVICE UNDER 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE. HOWEVER, BASED ON THE PRODUCT INVESTIGATION IT IS CONCLUDED THAT ROTATION OF THE GREEN TRIGGER WIRE KNOB DURING THE DEPLOYMENT PROCEDURE IS THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT, AS THERE WAS SMALL MARKS INSIDE THE GREEN TRIGGER WIRE KNOB. AS PER IFU THE GREEN TRIGGER WIRE KNOB SHOULD NOT BE ROTATED DURING DEPLOYMENT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. 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) 2016, A (B)(6) MALE PATIENT UNDERWENT TEVAR FOR ANEURYSM IN THE GREATER CURVATURE OF THE DESCENDING AORTA BY LEFT FEMORAL APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE, AND THE PROCEDURE WAS CONDUCTED AS LABELLED. PROCEDURE PLAN: PLACING ZTEG-2P-30-140-PF IN THE DISTAL SIDE FIRST, THEN ZTEG-2P-34-202-PF (COMPLAINT DEVICE) IN THE PROXIMAL SIDE. WHEN ATTEMPTING TO WITHDRAW THE TRIGGER-WIRES OF THE SECOND DEVICE (ZTEG-2P-34-202-PF), THE USER ENCOUNTERED STRONG RESISTANCE. AFTER CONFIRMING THAT THE GRAY POSITIONER WAS NOT TWISTED OR WARPED, HE REATTEMPTED TO WITHDRAW THEM SLOWLY BY HAND, BUT STRONG RESISTANCE WAS FELT AGAIN. THEREFORE, THE HUB OF THE GRAY POSITIONER WAS HELD/SECURED WITH TWO PEAN FORCEPS IN ORDER NOT TO LET THE DELIVERY SYSTEM MOVE, THEN THE USER TRIED TO WITHDRAW THEM SLOWLY AGAIN AND THE TRIGGER-WIRES COULD BE REMOVED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2016: A (B)(6) MALE PATIENT UNDERWENT TEVAR FOR ANEURYSM IN THE GREATER CURVATURE OF THE DESCENDING AORTA BY LEFT FEMORAL APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE, AND THE PROCEDURE WAS CONDUCTED AS LABELLED. PROCEDURE PLAN: PLACING ZTEG-2P-30-140-PF IN THE DISTAL SIDE FIRST, THEN ZTEG-2P-34-202-PF (COMPLAINT DEVICE) IN THE PROXIMAL SIDE. WHEN ATTEMPTING TO WITHDRAW THE TRIGGER-WIRES OF THE SECOND DEVICE (ZTEG-2P-34-202-PF), THE USER ENCOUNTERED STRONG RESISTANCE. AFTER CONFIRMING THAT THE GRAY POSITIONER WAS NOT TWISTED OR WARPED, HE REATTEMPTED TO WITHDRAW THEM SLOWLY BY HAND, BUT STRONG RESISTANCE WAS FELT AGAIN. THEREFORE, THE HUB OF THE GRAY POSITIONER WAS HELD/SECURED WITH TWO PEAN FORCEPS IN ORDER NOT TO LET THE DELIVERY SYSTEM MOVE, THEN THE USER TRIED TO WITHDRAW THEM SLOWLY AGAIN AND THE TRIGGER-WIRES COULD BE REMOVED. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821750 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526898

    Patients

    Seq Age Sex Outcome Treatment
    1 79 DA