BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 15542065 · Received October 5, 2022

    Report

    Report Number
    3002808486-2022-00967
    Event Type
    Death
    Date Received
    October 5, 2022
    Date of Event
    September 23, 2022
    Report Date
    January 5, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002448749
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER PMA/510(K) K140016. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A MALE PATIENT OF AN UNKNOWN AGE WITH ACUTE TYPE B DISSECTION WAS TREATED WITH A ZTA-PT-46-42-179-W1 (COMPLAINT DEVICE) ON (B)(6) 2022. THE PLAN WAS TO PRESERVE LSA BLOOD FLOW. ZTA WAS FENESTRATED AND IMPLANTED. THEN, A COVERED STENT WAS PLACED IN THE LSA. THE PHYSICIAN ADVANCED THE DEVICE WITH PENETRATION TO JUST BELOW THE LCCA AND DEPLOYED THE DEVICE UNTIL IT WAS HALFWAY OUT. AFTER THAT, A WIRE AND CATHETER WERE ADVANCED FROM THE LEFT RADIAL ARTERY TO LSA, AND CANNULATED INTO THE PENETRATION OF THE STENT GRAFT, BUT IT WAS NOT PROPERLY FACING THE GREATER CURVATURE. THEREFORE, POSITION CORRECTION WAS PERFORMED INFLATING WITH A STENT GRAFT BALLOON CATHETER (FROM ANOTHER MANUFACTURER). AFTER THE TEVAR WAS PERFORMED A DROP IN BLOOD PRESSURE WAS OBSERVED AND A CT SCAN REVEALED RETROGRADE TYPE A DISSECTION. TOTAL AORTIC ARCH REPLACEMENT WAS SCHEDULED TO BE PERFORMED, BUT THE PATIENT DIED ON (B)(6) 2022. NO AUTOPSY REPORT WAS PROVIDED. BY THE PHYSICIANS OPINION, SINCE BALLOONING WAS DONE SEVERAL TIMES, THIS TOUCH-UP WAS THE CAUSE OF RETROGRADE TYPE A DISSECTION. NO IMAGING WAS PROVIDED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. ACCORDING TO THE INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AND ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED IN THE PATIENT WITH DISSECTIONS. BASED ON THE PROVIDED INFORMATION BALLOONING MAY HAVE CAUSED RETROGRADE TYPE A DISSECTION. HOWEVER, THE USE OF ZTA DEVICE FOR TREATMENT OF DISSECTION MAY ALSO HAVE CONTRIBUTED TO THE REPORTED EVENT. IT IS NOTED THAT ZTA DEVICE WAS MODIFIED. DEVICE MODIFICATION IS NOT SUPPORTED BY THE INSTRUCTIONS FOR USE OR CLINICAL TESTING OF THE DEVICE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WITHIN THE RANGE OF IFU. THERE WAS NO PROBLEM FOR DEVICES WITH AN OD OF 7.7 MM FOR THE PATIENT'S VESSEL ID OF ABOUT 8 MM. THE PLAN WAS AS FOLLOWED AS TO PRESERVE LSA BLOOD FLOW. ZTA WAS FENESTRATED AND IMPLANTED. THEN, A COVERED STENT WAS PLACED IN THE LSA. (B)(6) 2022: TEVER CONDUCTED 26 SEP 2022: COOK SALES REP HAS RECEIVED THE INFORMATION FROM THE PERSON IN CHARGE OF THE DEALER, THE PATIENT DIED ON (B)(6) 2022. ADDITIONAL INFORMATION PROVIDED 30SEP2022: AN ACUTE TYPE B DISSECTION, CENTRAL NECK F42MM ONLY, OTHER DETAILS UNKNOWN. IT WAS DECIDED TO PERFORM TEVER, WHICH IS LESS INVASIVE THAN OPEN CHEST SURGERY OR BYPASS. THE PROCEDURE DID NOT GO AS PLANNED, BECAUSE THE PENETRATION WAS NOT PROPERLY ORIENTED TO THE GREATER CURVATURE. TEVAR WAS PERFORMED ON WEDNESDAY, AFTER WHICH A DROP IN BLOOD PRESSURE WAS OBSERVED AND A CT SCAN REVEALED AN TYPE A DISSECTION. TAR (TOTAL AORTIC ARCH REPLACEMENT) WAS SCHEDULED TO BE PERFORMED ON FRIDAY MORNING, BUT IT WAS TOO LATE AND THE PATIENT DIED ON EARLY FRIDAY MORNING (DAWN ON FRIDAY). RETROGRADE TYPE A DISSOCIATION IS THE REASON FOR DEATH. PHYSICIAN DETERMINES THAT IT WAS CAUSED BY THE PROCEDURE. PHYSICIAN ADVANCED THE DEVICE WITH PENETRATION TO JUST BELOW THE LCCA AND DEPLOYED THE DEVICE UNTIL IT WAS HALFWAY OUT. AFTER THAT, A WIRE AND CATHETER WERE ADVANCED FROM THE LEFT RADIAL ARTERY TO LSA, AND CANNULATED INTO THE PENETRATION OF THE STENT GRAFT, BUT IT WAS NOT PROPERLY FACING THE GREATER CURVATURE. THEREFORE, POSITION CORRECTION WAS PERFORMED WHILE INFLATING WITH A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC). SINCE THIS WAS DONE SEVERAL TIMES, THIS TOUCH-UP WAS THE CAUSE OF RETROGRADE TYPE A DISSECTION. PATIENT OUTCOME: THE PATIENT DIED ON (B)(6) 2022.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675841 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4024292 10827002448749

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death