BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 5764252 · Received July 1, 2016

    Report

    Report Number
    3002808486-2016-00638
    Event Type
    Death
    Date Received
    July 1, 2016
    Date of Event
    June 6, 2016
    Report Date
    June 6, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P070016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. SIMILAR TO DEVICE WITH 510(K) P070016. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS LIMITED TO THE DESCRIPTION OF EVENT, PATIENT OUTCOME AND THE COMMENTS PROVIDED FROM THE SALES REP AND THE PHYSICIAN. ACCORDING TO THE INFORMATION, THE PRODUCT DID NOT CONTRIBUTE TO THIS EVENT AND THE EVENT IS LIKELY RELATED TO THE PATIENT CONDITION. NO FURTHER INFORMATION COULD BE OBTAINED. THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN WHY NO REVIEW OF THE WORK ORDER WAS CONDUCTED IN THIS INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PT IDENTIFIER) UNKNOWN AS INFORMATION WAS NOT PROVIDED. WEIGHT) UNKNOWN AS INFORMATION WAS NOT PROVIDED. LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. SIMILAR TO DEVICE WITH 510(K) P070016. DEVICE MANUFACTURE DATE) UNKNOWN AS LOT# IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS LIMITED TO THE DESCRIPTION OF EVENT, PATIENT OUTCOME AND THE COMMENTS PROVIDED FROM THE SALES REP AND THE PHYSICIAN. ACCORDING TO THE INFORMATION, THE PRODUCT DID NOT CONTRIBUTE TO THIS EVENT AND THE EVENT IS LIKELY RELATED TO THE PATIENT CONDITION. NO FURTHER INFORMATION COULD BE OBTAINED. THE LOT NUMBER OF THE COMPLAINT DEVICE IS UNKNOWN WHY NO REVIEW OF THE WORK ORDER WAS CONDUCTED IN THIS INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: A (B)(6) MALE PATIENT UNDERWENT EMERGENCY TEVAR FOR IMPENDING RUPTURE OF TYPE B AORTIC DISSECTION. THERE WAS NO PROBLEM WITH ACCESS ROUTE, HOWEVER, SINCE BLEEDING POINT WAS NOT DETECTED, IT WAS PLANNED THAT THE WHOLE THORACIC REGION IS COVERED BY THREE DEVICES (ZTEG-2PT-32-200-PF-D (LOT # UNKNOWN), ESBE-26-80-T-PF-D (LOT # UNKNOWN) AND ESBE-28-80-T-PF-D (LOT # UNKNOWN)) AND TXD BARE STENT IS IN THE DISTAL LESION. AFTER PLACEMENT OF THREE DEVICES, RERUPTURE OCCURRED AND THE BLOOD PRESSURE DID NOT RECOVER. THE PATIENT WAS CONFIRMED DEAD. PATIENT OUTCOME: THE PATIENT DIED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: A (B)(6) MALE PATIENT UNDERWENT EMERGENCY TEVAR FOR IMPENDING RUPTURE OF TYPE B AORTIC DISSECTION. THERE WAS NO PROBLEM WITH ACCESS ROUTE, HOWEVER SINCE BLEEDING POINT WAS NOT DETECTED, IT WAS PLANNED THAT THE WHOLE THORACIC REGION IS COVERED BY THREE DEVICES (ZTEG-2PT-32-200-PF-D (LOT # UNKNOWN), ESBE-26-80-T-PF-D (LOT # UNKNOWN) AND ESBE-28-80-T-PF-D (LOT # UNKNOWN)) AND TXD BARE STENT IS IN THE DISTAL LESION. AFTER PLACEMENT OF THREE DEVICES, RERUPTURE OCCURRED AND THE BLOOD PRESSURE DID NOT RECOVER. THE PATIENT WAS CONFIRMED DEAD. PATIENT OUTCOME: THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418569 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death