BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 15500225 · Received September 28, 2022

    Report

    Report Number
    3002808486-2022-00965
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 24, 2022
    Report Date
    October 5, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449180
    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) P140016. 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

    MANUFACTURER REF# (B)(4). THIS COMPLAINT IS NO LONGER REPORTABLE AS PHYSICIAN INFORMED THE PATIENT DEATH WAS DUE TO PATIENT CONDITION, AND THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEATH. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2022: AT NIGHT, EMERGENCY TEVAR WAS CONDUCTED FOR TAA RUPTURE CASE. THE TREATMENT AREA WAS APPROX 160MM-170MM AND THE PHYSICIAN PLACED ZTA-DE-34-112-W1 FIRST. THEN HE PLACED A STENT GRAFT FROM ANOTHER MANUFACTURER INSIDE THE ZTA-DE-34-112-W1. OVERLAP LENGTH WAS APPROX 90MM. THE DISTAL END OF ZTA-DE-34-112-W1 WAS PLACED AT THE LEVEL OF AORTIC VALVE. THE PROXIMAL END OF GORE'S C-TAG WAS PLACED AT THE ZONE 3 AND ITS DISTAL END WAS PLACED INSIDE THE ZTA-DE-34-112-W1. THE PLACEMENT WAS COMPLETED, BUT THE PATIENT'S CONDITION WAS BAD. HE CLOSED INCISION AND THE PATIENT WAS SENT TO ICU. ON (B)(6) 2022: THE PATIENT'S CONDITION DID NOT GET BETTER AND THE PATIENT DECEASED IN THE MORNING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 04OCT2022. THE PHYSICIAN INFORMED COOK THAT THE PATIENT DEATH WAS DUE TO PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045561 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4267702 10827002449180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death