BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6321298 · Received February 10, 2017

    Report

    Report Number
    3002808486-2017-00380
    Event Type
    Death
    Date Received
    February 10, 2017
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527154
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS:IT WAS NOT POSSIBLE TO CONCLUDE AN ROOT CAUSE FOR THIS EVENT. NOTHING HOWEVER INDICATES THAT THE DEVICE WAS DEFECTIVE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2014, A FEMALE PATIENT IN 70'S HAD A ANEURYSM RUPTURE AND WAS FLOWN ON A HELICOPTER TO THE HOSPITAL URGENTLY FOR REPAIR. THE PHYSICIAN DETERMINED ENDOVASCULAR REPAIR WAS THE ONLY CHOICE FOR THIS CASE. THE ACCESS VESSEL WAS SLIGHTLY THIN, SO A SHEATH (GORE/DRYSEAL SHEATH) WAS USED AS A DUMMY SHEATH TO CHECK THE ACCESS VESSEL. ESBE-34-77-T-PF WAS PLACED IN THE DISTAL SIDE DUE TO THIN VESSEL. THE LEFT SUBCLAVIAN VEIN WAS COIL EMBOLIZED TO ENSURE THE LANDING ZONE AND ZTEG-2PT-40-158-PF WAS PLACES AS LABELED. PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, SO ESBE-40-81-T-PF WAS ADDITIONALLY PLACED. IT ENDED UP COVERING THE LEFT COMMON CAROTID ARTERY, SO CHIMNEY WAS CREATED WITH A STENT (BARD/12MM LUMINEXX). THE FINAL ANGIOGRAPHY CONFIRMED SLIGHT ENDOLEAK, SO THE PHYSICIAN ATTEMPTED TO FIND THE LEAK SITE BY ANGIOGRAPHY BUT COULDN'T FIND IT. WHEN HE PERFORMED CEREBRAL ANGIOGRAPHY, HE FOUND CEREBRAL ANEURYSM AND DETERMINED THAT FURTHER ANGIOGRAPHY WOULD BE RISKY AND COMPLETED THE PROCEDURE. ON (B)(6) 2014, THE ANEURYSM RUPTURED AGAIN AND THE PATIENT DECEASED. NO AUTOPSY WAS PERFORMED. PATIENT OUTCOME: THE PATIENT DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105674 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527154

    Patients

    Seq Age Sex Outcome Treatment
    1 Death