BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 20350327 · Received October 2, 2024

    Report

    Report Number
    3002808486-2024-00205
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    August 12, 2024
    Report Date
    May 13, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). H6) C22 - APPROPRIATE INVESTIGATION FINDINGS TERM/CODE NOT AVAILABLE: SIDE-EFFECT. AFTER INVESTIGATION THE EVENT FOR THIS PR# IS NO LONGER REPORTABLE. 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 ROUTINELY TREATED FOR SACCULAR THORACIC AORTIC ANEURYSM WITH PLACEMENT OF A ZTA-DE-34-112 (COMPLAINT DEVICE). NO PROCEDURE ISSUES WERE REPORTED. THE DEVICE WAS INTACT AND NO ENDOLEAK NOTED AT CLOSE OF PROCEDURE AND AT 1-MONTH AND 12-MONTH FOLLOW-UP VISITS. THE 2-YEAR FOLLOW-UP IMAGING ((B)(6) 2021) REVEALED DEVICE MIGRATION > 10 MM AND A TYPE 1B ENDOLEAK. AN ADVERSE EVENT WAS ENTERED FOR THE ENDOLEAK, BUT RELATIONSHIP TO DEVICE, PROCEDURE, AND AORTIC DISEASE WAS NOTED AS ¿RETROSPECTIVE EVENT, UNABLE TO DETERMINE.¿ ON (B)(6) 2021, A SECONDARY INTERVENTION, ENDOVASCULAR PLACEMENT OF A DISTAL COMPONENT GRAFT, WAS PERFORMED WITH THE INDICATION NOTED AS DEVICE MIGRATION. NO IMAGING WAS PROVIDED. BASED ON THE PROVIDED EVIDENCE AND THE COMPLETED INVESTIGATION, COOK HAS DETERMINED THAT A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED, HOWEVER, COMPONENT MIGRATION AND ENDOLEAK ARE KNOWN INHERENT RISKS ASSOCIATED WITH THIS DEVICE ACCORDING TO THE INSTRUCTION FOR USE (IFU). NOTHING INDICATES DEVICE DEFICIENCY AND SINCE THE ADVERSE EVENT OCCURRED 2 YEARS POST-IMPLANT, IT IS POSSIBLE THAT THE EVENT OF MIGRATION AND ENDOLEAK OCCURRED DUE TO DISEASE PROGRESSION OR AORTIC ELONGATION AND THEREFORE ASSESSED AS A SIDE-EFFECT INHERENT TO PATIENT MEDICAL CONDITION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 WCE-1713: ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY: SYNOPSIS: PROTOCOL 17-13, PATIENT 612-002: 2-YEAR FOLLOW-UP IMAGING REVEALED DEVICE MIGRATION > 10 MM AND A TYPE 1B ENDOLEAK PROMPTING A SECONDARY INTERVENTION TO PLACE AN ADDITIONAL DISTAL COMPONENT GRAFT. ON (B)(6) 2019, THE PATIENT WAS ROUTINELY TREATED FOR SACCULAR THORACIC AORTIC ANEURYSM WITH PLACEMENT OF A ZTA-DE-34-112. NO PROCEDURE ISSUES WERE REPORTED. THE DEVICE WAS INTACT AND NO ENDOLEAK NOTED AT CLOSE OF PROCEDURE AND AT 1-MONTH AND 12-MONTH FOLLOW-UP VISITS. THE 2-YEAR FOLLOW-UP IMAGING (B)(6) 2021 REVEALED DEVICE MIGRATION > 10 MM AND A TYPE 1B ENDOLEAK. AN AE WAS ENTERED FOR THE ENDOLEAK, BUT RELATIONSHIP TO DEVICE, PROCEDURE, AND AORTIC DISEASE WAS NOTED AS ¿RETROSPECTIVE EVENT, UNABLE TO DETERMINE.¿ ON (B)(6) 2021, A SECONDARY INTERVENTION, ENDOVASCULAR PLACEMENT OF A DISTAL COMPONENT GRAFT, WAS PERFORMED WITH THE INDICATION NOTED AS DEVICE MIGRATION. PATIENT OUTCOME: THE SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. THE 3-YEAR FOLLOW-UP IMAGING (B)(6) 2023 SHOWED NO FURTHER MIGRATION AND NO ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915556 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34613 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention