BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 23207706 · Received October 3, 2025

    Report

    Report Number
    3002808486-2025-00219
    Event Type
    Injury
    Date Received
    October 3, 2025
    Date of Event
    September 22, 2025
    Report Date
    April 28, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 510(K)/PMA: P140016. H10) FDA 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS PERFORMED FOR THE AORTIC ARCH. A BYPASS WAS CREATED FOR THE PROXIMAL LEFT SUBCLAVIAN ARTERY, AND A ZTA-P-38-217-W1 STENT GRAFT WAS DEPLOYED JUST BELOW ZONE 2 (LEFT COMMON CAROTID ARTERY). DURING THE FINAL ANGIOGRAPHY, PROXIMAL TYPE 1 ENDOLEAK WAS IDENTIFIED. AN ADDITIONAL EXTENSION WAS PLANNED; HOWEVER, THE TIP OF THE EXTENSION DEVICE (ZTA-DE-38-91-W1) BECAME STUCK AT THE ARCH LEVEL AND COULD NOT BE DELIVERED. A PULL-THROUGH TECHNIQUE WAS CONSIDERED, BUT DUE TO THE PRESENCE OF THE BYPASS, IT WAS DEEMED TOO RISKY. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE DEVICE, BUT ALL WERE UNSUCCESSFUL. ULTIMATELY, THE ATTEMPTS WERE HALTED, AND A FOLLOW-UP ANGIOGRAPHY REVEALED THAT THE ENDOLEAK HAD RESOLVED SPONTANEOUSLY. BALLOON MOLDING WAS PERFORMED TO SECURE THE DEVICE IN PLACE, AFTER WHICH THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433508 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44963 E4702055

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female