BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 5982733 · Received September 28, 2016

    Report

    Report Number
    3002808486-2016-01176
    Event Type
    Injury
    Date Received
    September 28, 2016
    Report Date
    September 3, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE (B)(4). SIMILAR TO DEVICE UNDER P140016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE AVAILABLE INFORMATION FOR THIS COMPLAINT WAS ONLY THE EVENT DESCRIPTION AS NO IMAGING OR LOT NUMBER WAS PROVIDED. IT WAS THEREFORE NOT POSSIBLE TO DETERMINE THE CAUSE OF THE EVENT. ACCORDING TO THE IFU THIS EVENT IS LISTED AS A POTENTIAL ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: THIS (B)(6) YR OLD FEMALE PATIENT IN THE (B)(6) STUDY HAD A TYPE III ENDOLEAK NOTED ON THE FOLLOW-UP CT (4 DAYS PP). ON (B)(6) 2016, A PROXIMAL COMPONENT AND A DISTAL COMPONENT WERE IMPLANTED WITHOUT DIFFICULTY. NO ADDITIONAL PROCEDURES OR DEVICES WERE NEEDED. ON THE FINAL COMPLETION ANGIOGRAM, NO ENDOLEAKS WERE NOTED. FOLLOW-UP CT¿S: (B)(6) 2016 (4 DAYS PP) A TYPE 3 ENDOLEAK WAS NOTED ¿AT THE 1/3 DISTAL OF THE DESCENDING AORTA¿. NO OTHER TECHNICAL OBSERVATIONS/IMAGING ABNORMALITIES OBSERVED, INCLUDING KINK, STENT FRACTURE, BARB SEPARATION, AND COMPONENT SEPARATION. THIS FINDING OF A TYPE III ENDOLEAK DID NOT RESULT IN A NEW CLINICAL EVENT OR INTERVENTION. PATIENT OUTCOME: NO INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637253 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Life Threatening