BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 12460224 · Received September 13, 2021

    Report

    Report Number
    3002808486-2021-01785
    Event Type
    Death
    Date Received
    September 13, 2021
    Date of Event
    August 6, 2021
    Report Date
    February 15, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002448763
    PMA / PMN Number
    P140016
    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). SUMMARY OF INVESTIGATIONAL FINDINGS: A 79-YEAR-OLD MALE PATIENT UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) ON (B)(6) 2021 WITH A ZTA-D-28-160-W1 (COMPLAINT DEVICE) AND A ZTA-DE-30-108-W1, WHICH WERE IMPLANTED IN THE ABDOMINAL AND THE THORACIC AORTA. IT IS UNKNOWN IN WHAT ORDER THE DEVICES WERE PLACED. THE PATIENT´S PREEXISTING CONDITION WAS REPORTED WITH MULTIPLE CEREBRAL INFARCTIONS AND CHRONIC RENAL FAILURE. THE PATIENT WAS TRANSFERRED TO ICU AFTER TEVAR AND STARTED ON DIALYSIS THE FOLLOWING DAY. THE COLOR OF PATIENT´S RIGHT TOE GRADUALLY DETERIORATED. THE RIGHT FOOT AMPUTATION WAS PERFORMED DUE TO GANGRENE. THE PATIENT WAS INTUBATED AND PLACED ON A VENTILATOR DUE TO RESPIRATORY FAILURE. IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CHOLESTERIN EMBOLISM ON (B)(6) 2021. THE PHYSICIAN STATES THAT EMBOLISM CAUSED BY BLOOD CLOTS INCLUDING ATHEROMA ALONE DOES NOT CAUSE DEATH. THE PHYSICIAN ASSUME THAT IT IS LIKELY THAT CHOLESTERIN CRYSTALS CAUSED EMBOLISM AT THE MICRO LEVEL, RESULTING IN ACUTE MULTIORGAN FAILURE AND DEATH. THE AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN STATES THAT IT IS UNKNOWN IF THE DEATH WAS RELATED TO THE DEVICES. PER THE CLINICAL ASSESSMENT ¿THE INFORMATION IN THIS COMPLAINT IS VERY SPARSE THUS NO DIRECT LINK BETWEEN THE DEVICE USED AND THE PATIENT¿S DEATH CAN BE ESTABLISHED¿. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. PER THE IFU, EMBOLIZATION (MICRO AND MACRO) WITH TRANSIENT OR PERMANENT ISCHEMIA OR INFARCTION IS A KNOWN ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION AND THE CLINICAL ASSESSMENT IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE CAUSE OF THE REPORTED EVENT. IT IS NOTED THAT A ZTA DEVICE WAS USED IN THE ABDOMINAL AORTA WHICH IS OUTSIDE OF INTENDED USE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2021: ZTA-D-28-160-W1/E4060008 AND ZTA-DE-30-108-W1/E3831643 WERE PLACED IN THE ABDOMINAL AORTA AND THORACIC AORTA. PATIENT OUTCOME: (B)(6) 2021: THE PATIENT EXPIRED DUE TO CHOLESTERIN EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356960 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E4060008 10827002448763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death