BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 20961532 · Received December 18, 2024

    Report

    Report Number
    3002808486-2024-00261
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    December 14, 2022
    Report Date
    May 20, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF# (B)(4). H6) C22 APPROPRIATE TERM/CODE NOT AVAILABLE: SIDE-EFFECT. AFTER INVESTIGATION THE EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AS NO DEVICE DEFICIENCY OR MALFUNCTION OCCURRED. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A POST MARKET CLINICAL FOLLOW-UP (PMCF) STUDY COOK BECAME AWARE OF THIS EVENT. ON (B)(6) 2019, THE PATIENT WAS EMERGENTLY TREATED FOR PENETRATING AORTIC ULCER WITH INTRAMURAL HEMATOMA WITH PLACEMENT OF A ZTA-PT-36-32-209 (COMPLAINT DEVICE) FROM ZONE 3. THE PATIENT WAS DISCHARGED ON ANTIPLATELETS AND ASPIRIN. ON (B)(6) 2020 (447 DAYS POST-PROCEDURE) NON-CONTRAST IMAGING COMPLETED SHOWED THAT THE DEVICE AND ALL VESSELS WERE PATENT, AND THERE WAS NO EVIDENCE OF THROMBUS, DEVICE ISSUE, OR ENDOLEAK. THE PATIENT WAS NO LONGER TAKING ANTIPLATELETS OR ASPIRIN AT THIS TIME. ON (B)(6) 2022 ON THE 4-YEAR FOLLOW-UP IMAGING (1280 DAYS POST-PROCEDURE) IMAGING REVEALED PATENT STUDY DEVICE WITH THROMBUS, OCCLUDED LSA (LEFT SUBCLAVIAN ARTERY), NO DEVICE ISSUES, AND NO ENDOLEAKS. LSA WAS OCCLUDED DUE TO TIGHT STENOSIS OF THE FIRST FEW CENTIMETERS OF THE LEFT SUBCLAVIAN ARTERY UPSTREAM OF THE ORIGIN OF THE LEFT VERTEBRAL ARTERY. NO INFORMATION REGARDING IN-GRAFT THROMBUS WAS PROVIDED. NO EVIDENCE OF DEVICE ISSUE WAS REPORTED. THROMBUS IS A KNOWN POTENTIAL ADVERSE EVENT. NOTHING INDICATES THAT THE EVENT IS RELATED TO A FAULT CONDITION OF THE DEVICE, THE THROMBUS IS ASSESSED AS AN ADVERSE EFFECT INHERENT TO THIS TYPE OF PROCEDURE WHY THE EVENT IS ASSESSED TO BE A SIDE EFFECT. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016 INVESTIGATION IS STILL IN PROGRESS. 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

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

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY (B)(6): ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY): THROMBUS IN THE STUDY DEVICE WAS REPORTED ON THE 4-YEAR FOLLOW-UP IMAGING. ON (B)(6) 2019, THE PATIENT WAS EMERGENTLY TREATED FOR PENETRATING AORTIC ULCER WITH INTRAMURAL HEMATOMA WITH PLACEMENT OF A ZTA-PT-36-32-209. THE PATIENT WAS DISCHARGED ON ANTIPLATELETS AND ASPIRIN. ON (B)(6) 2020 (447 DAYS POST-PROCEDURE) NON-CONTRAST IMAGING SHOWED THAT THE DEVICE AND ALL VESSELS WERE PATENT, AND THERE WAS NO EVIDENCE OF THROMBUS, DEVICE ISSUE, OR ENDOLEAK. THE PATIENT WAS NO LONGER TAKING ANTIPLATELETS OR ASPIRIN AT THIS TIME. ON (B)(6) 2022 (1280 DAYS POST-PROCEDURE) IMAGING REVEALED PATENT STUDY DEVICE WITH THROMBUS, OCCLUDED LEFT SUBCLAVIAN ARTERY, NO DEVICE ISSUES, AND NO ENDOLEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279462 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34645 E3774154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown