BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6313665 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00374
    Event Type
    Death
    Date Received
    February 9, 2017
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526867
    Adverse Event
    Yes
    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: BASED ON THE LIMITED INFORMATION AVAILABLE IT HAS NOT BEEN POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER THERE IS NO INDICATION OF A DEFECTIVE DEVICE. WEAK VESSEL CONDITION SEEMS AS THE MOST LIKELY REASON FOR AORTA RUPTURE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE 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 INITIAL REPORTER: DATE UNKNOWN: TAR WITH PLACING ELEPHANT TRUNK WAS PERFORMED. ON (B)(6) 2013 AT 9:00, AN (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE AORTA HAD DISSECTION. AT 10:30, CANNULATION INTO THE ELEPHANT TRUNK WAS PERFORMED AND ZTEG-2P-32-200-PF WAS INSERTED FROM THE RIGHT FEMORAL. AT 10:40, THE AORTA RUPTURED DURING THE DELIVERY SYSTEM WAS ADVANCING INTO THE ELEPHANT TRUNK. RESUSCITATION WAS PERFORMED. OTHER ADDITIONAL TREATMENT WAS NOT PERFORMED BECAUSE STABILITY OF HEMODYNAMIC COULD NOT BE ACHIEVED. AT 11:40, THE PATIENT WAS TRANSFERED TO ICU BUT HE DECEASED DUE TO SHOCK FROM EXCESSIVE BLEEDING. ADDITIONAL INFORMATION RECEIVED 31JAN2013: AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN COMMENTED THAT THE DEVICE DIDN'T CAUSE THE DEATH, IT'S DUE TO WEAK VESSEL CONDITION. PATIENT OUTCOME: THE PATIENT WAS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100169 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526867

    Patients

    Seq Age Sex Outcome Treatment
    1 82 Death