BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION

    MDR report key: 6331037 · Received February 15, 2017

    Report

    Report Number
    3002808486-2017-00388
    Event Type
    Death
    Date Received
    February 15, 2017
    Date of Event
    September 12, 2013
    Report Date
    September 12, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526416
    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: NO PRODUCT, PHOTOS OR IMAGING RECEIVED TO SUPPORT THE INVESTIGATION OF THIS COMPLAINT. BASED ON THE DESCRIPTION OF EVENT, AND THE STATEMENT OF THE PHYSICIAN IT IS BELIEVED THAT "THE DISSECTION OCCURRED WHEN THE FIRST DROP OF THE BLOOD PRESSURE WHEN TRYING TO DELIVER THE FIRST RELAY, AND THE FORCED ADVANCEMENT OF THE REPLACED RELAY." BASED ON THIS INFORMATION IT IS BELIEVED THAT THE DISSECTION OBSERVED IS NOT RELATED TO DEVICE PERFORMANCE, BUT RATHER TO PATIENT CONDITION OR THE OTHER DEVICES USED. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED 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) 2013: AN (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE ANEURYSM WAS IN ZONE 0, AND FROM ZONE 2 TO ZONE 4. THE DESCENDING AORTA WAS ANGLED AT APPROX 40 DEGREES AT APPROX 7CM ABOVE THE CELIAC ARTERY. IT DIDN'T SEEM THERE WAS SIZE PROBLEM OR CALCIFICATION IN THE ACCESS VESSEL (RIGHT). THE PROCEDURE WAS PLANNED AS PLACING GORE'S TAG IN THE ZONE 0, BOLTON'S RELAY IN THE ZONE 2 TO ZONE 4 AND ESBE-34-77-T-PF TO SECURE SEALING OF THE DISTAL OF THE BOLTON'S RELAY. USING GORE'S DRYSEAL SHEATH, GORE TAG WAS PLACED AS PLANNED WITH NO PROBLEM. THEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE RELAY TO THE TARGET SITE IN THE AORTA ARCH BUT THE DELIVERY SYSTEM GOT CAUGHT IN THE TORTUOUS PART IN THE DESCENDING AORTA. HE ATTEMPTED TO ADVANCE IT WITH FORCE, BUT THE DELIVERY SYSTEM KINKED. AT THIS TIME, TEMPORARY DROP OF BLOOD PRESSURE WAS CONFIRMED, AND HE CHECKED THE PATIENT'S CONDITION AND CONTINUED THE PROCEDURE. HE REPLACED THE RELAY WITH ANOTHER RELAY AND TRIED AGAIN WITH PULL-THROUGH TECHNIQUE, BUT IT STILL WOULDN'T PASS THE TORTUOUS PART. THEN HE PUSHED IT WITH FORCE, AND THE DELIVERY SYSTEM BECAME OFF THE TORTUOUS PART TO BE ADVANCED AND THE STENT GRAFT WAS PLACED AT THE TARGET SITE, RIGHT BELOW THE SUBCLAVIAN. AT THIS TIME, THE BLOOD PRESSURE WAS STABLE. HOWEVER APPROX 7CM OF THE DISSECTION FROM THE DISTAL OF THE RELAY TO THE CELIAC WAS CONFIRMED, SO HE PLACED ESBE-34-77-T-PF. 10 MINUTES AFTER PLACEMENT OF ESBE-34-77-T-PF, DURING DISCUSSING ABOUT NEXT STEP TO TREAT THE DISSECTION, THE BLOOD PRESSURE SEVERELY DROPPED, SO CARDIAC COMPRESSION WAS PERFORMED FOR ABOUT 20 MINUTES. THEN PCPS WAS PERFORMED, BUT THE PATIENT SUFFER CARDIOPULMONARY ARREST AND DECEASED. PATIENT OUTCOME: THE PATIENT SUFFERED CARDIOPULMONARY ARREST AND DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113838 ZENITH TX2 TAA ENDOVASCULAR GRAFT TAA ANCILLARY COMPONET DISTAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526416

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death