BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 10127285 · Received June 8, 2020

    Report

    Report Number
    3002808486-2020-00585
    Event Type
    Death
    Date Received
    June 8, 2020
    Date of Event
    May 1, 2016
    Report Date
    June 8, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). THE EVENT IS CONSIDERED AS NOT REPORTABLE AS THIS EVENT HAS NO INDICATION NOR ANY INFORMATION THAT THE DEVICE WAS IN ANY WAY RELATED TO THE DEATH OF THE PATIENT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K)) SIMILAR TO DEVICE UNDER PMA/510(K) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: UNKNOWN DEATH. ON (B)(6) 2016 THE FOLLOWING TWO DEVICES WAS IMPLANTED: LOT#: E3366866, CATALOG#: ZTA-P-36-161 - PROXIMAL COMPONENT, LOT#: E3399119, CATALOG#: ZTA-D-38-147 - DISTAL COMPONENT. THE LEFT SUBCLAVIAN ARTERY (LSA) WAS NOT COVERED BY THE STENT GRAFT. IMPLANTATION WAS DONE IN ZONE 4. NO OTHER ADDITIONAL PROCEDURES WERE COMPLETED PRIOR OR DURING THE IMPLANTATION OF THE STUDY DEVICE. ON THE FINAL COMPLETION ANGIOGRAM, THERE WAS NO EVIDENCE OF AN UNCORRECTED ENDOLEAK NEITHER REPORTABLE ADVERSE EVENTS OBSERVED DURING THE IMPLANT PROCEDURE. ON (B)(6) 2016 (4 DAYS POST-PROCEDURE), A FOLLOW-UP CT REVEALED NO TECHNICAL OBSERVATIONS/IMAGING ABNORMALITIES. MAXIMUM ANEURYSM/DISSECTION/ULCER DIAMETER (MM) 60 AND THE TOTAL LENGTH OF COVERED AORTA (MM) 340. THE PATIENT DIDN'T COME OR CANCELLED THE 1 YEAR FOLLOW UP VISIT. THE 2 AND 3 YEARS FOLLOW UP VISITS WAS NOT DONE DUE TO STANDARD OF CARE AT THE SITE. (IN THIS STUDY THE PATIENT FOLLOW ¿THE STANDARD OF CARE PROGRAM¿ AT THE SPECIFIC HOSPITAL/CLINIQUE) ON THE (B)(6) 2016 THE PATIENT HAD AN EVENT OF (B)(6). THE EVENT WAS MARKED AS ¿ONGOING. THE TREATMENT WAS A DIAGNOSTIC PROCEDURE. THIS EVENT WAS NOT CONSIDERED AS BEING RELATED TO STUDY DEVICE OR STUDY PROCEDURE. ON (B)(6) 2020 (1589 DAYS POST-PROCEDURE) THE PATIENT¿S DEATH WAS REPORTED TO THE CRF. THE CAUSE OF DEATH AND THE DATE OF DEATH WAS UNKNOWN. FOLLOWING COMMENT WAS MADE BY THE SITE: ¿THE EXACT DAY AND MONTH OF THE DEATH IS UNKNOWN IN 2016.¿ FURTHERMORE, IF THE DEATH WAS RELATED TO DISEASE IS ALSO UNKNOWN. NO AUTOPSY WAS PERFORMED. NO DEATH REPORT OR AUTOPSY REPORT ARE AVAILABLE. THE PATIENT HAD A THORACIC AORTIC STENT GRAFT AT THE TIME OF DEATH. FOLLOWING COMMENT WAS MADE BY THE SITE: ¿UNKNOWN. PATIENT FAMILY HAVE BEEN CONTACTED BY PHONE BY THE RC BUT THE EXACT DATE AND DETAILS OF THE CIRCUMSTANCES SURROUNDING THE DEATH OF THE PATIENT COULD NOT BE OBTAINED. THE HOSPITAL WHERE THE PATIENT WAS HOSPITALIZED AFTER THE PROCEDURE CAN'T BE REACH BY PHONE DESPITE SEVERAL ATTEMPTS.¿ PATIENT OUTCOME: THE PATIENT DIED FROM AN UNKNOWN REASON ON AN UNKNOWN DATE IN 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591166 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3399119 10827002346540

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death