BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 17539165 · Received August 14, 2023

    Report

    Report Number
    3002808486-2023-00217
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    May 28, 2019
    Report Date
    September 25, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). THIS COMPLAINT IS NO LONGER CONSIDERED REPORTABLE WILL BE CANCELLED AS THE TYPE 1B ENDOLEAK IS ASSESSED TO BE RELATED TO THE STAGED PROCEDURE ON (B)(4) 2019 AND NO LONGER PRESENT ON A CT COMPLETED (B)(6) 2019 (88 DAYS POST-PROCEDURE). 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). 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). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE UNDER PMA: (B)(4). 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 30AUG2023: THE SITE DID INDICATE ON THE SCREENING QUESTIONNAIRE THAT THE PATIENT WAS ENROLLED AS A RETROSPECTIVE REVIEW AND THAT THE PATIENT IS DECEASED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 15AUG2023: ZTA-P-28-201 WAS PLACED MOST PROXIMAL (SEQUENCE NUMBER 1). ZTA-PT-32-28-201 WAS PLACED MOST DISTAL (SEQUENCE NUMBER 2). LOCATION OF GRAFT MATERIAL OF PROXIMAL EDGE OF THE MOST PROXIMAL COMPONENT WAS ¿ZONE 3: FIRST 2CM DISTAL TO LSA.¿ LOCATION OF GRAFT MATERIAL OF DISTAL EDGE OF THE MOST DISTAL COMPONENT WAS ¿ABOVE CELIAC.¿ PROXIMAL NECK: PARALLEL SHAPE WITH NO THROMBUS, NO TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. DISTAL NECK: PARALLEL SHAPE WITH NO THROMBUS, NO TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE SITE MARKED THAT THERE WERE NO PROCEDURES PRIOR TO THE ZTA IMPLANTATION AS PART OF THE OVERALL STRATEGY FOR REPAIR OF THE TREATED DISEASE AND THAT NO ADDITIONAL PROCEDURE(S) WERE PERFORMED DURING THE STUDY PROCEDURE. ADDITIONAL INFORMATION RECEIVED 23AUG2023: THE TYPE IB (DISTAL) ENDOLEAK WAS ALSO PRESENT ON A CT COMPLETED ON (B)(6) 2019 (6 DAYS POST-PROCEDURE) AND WAS NOT PRESENT ON A CT COMPLETED ON (B)(6) 2019 (88 DAYS POST-PROCEDURE). THE CT COMPLETED ON (B)(6) 2019 DID SHOW A TYPE II ENDOLEAK. A STAGED PROCEDURE WAS COMPLETED ON (B)(6) 2019 (70 DAYS POST-PROCEDURE) THAT WAS FOR T-BRANCH PLACEMENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: THE STUDY DEVICE(S) ARE PATENT AFTER GRAFT WAS COMPLETELY IMPLANTED. PROCEDURE ANGIOGRAPHY, ENDOLEAK TYPE IB. NO EVIDENCE OF DEVICE ISSUE(S) AT THE COMPLETION OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049911 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN 10827002346847

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown