BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6313664 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00362
    Event Type
    Death
    Date Received
    February 9, 2017
    Report Date
    October 16, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527178
    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 PROVIDED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. THE MOST LIKELY CAUSE CAN BE RELATED TO INCOMPLETE SEALING OF THE STENT GRAFT WITHIN THE VESSEL (4 MM VS. <25 MM AS PER IFU) RESULTED IN A TYPE I ENDOLEAK. THE DEATH OF THE PATIENT MAY BE RELATED TO ANEURYSM RUPTURE GIVEN THE NATURAL HISTORY OF TYPE I ENDOLEAKS. HOWEVER DUE TO THE PATIENT'S SEVERELY DISEASED CORONARY ARTERIES AN ACUTE MYOCARDIAL INFARCTION COULD JUST AS WELL HAVE BEEN THE ROOT CAUSE OF EXPIRY OF THE PATIENT. NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS WHICH IS SUPPORTED BY THE PHYSICIAN'S COMMENTS. 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 (B)(6) MALE PATIENT WITH A BOVINE ARCH UNDERWENT TAA REPAIR. THE TAA WAS 7 CM OF SACCULAR ANEURYSM AND THE LANDING ZONE AT THE PROXIMAL SIDE WAS SHORTISH, SO THE PHYSICIAN PLANNED TO PLACE THE STENT GRAFT TO COVER SOME PART OF OVINE ARCH TO GET MORE LANDING ZONE. AFTER PLACEMENT OF ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT (ZTEG-2PT-40-208-PF), PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED. HE PLACED ANOTHER ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT (ZTEG-2PT-40-208-JP) AND CONFIRMED THE ENDOLEAK WAS RESOLVED AND COMPLETED THE PROCEDURE. ON (B)(6) 2014: AT THE TIME OF DISCHARGE, SLIGHT PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, BUT THE PHYSICIAN DETERMINED IT WILL BE THROMBOSED AND THE PATIENT DISCHARGED. ON (B)(6) 2014: THE PATIENT'S CONDITION CHANGED AND WAS TOOK TO ANOTHER HOSPITAL WHERE HAD BEEN TREATING HIS RENAL FAILURE, AND HE SUFFERED CARDIOPULMONARY ARREST DURING GETTING TO THE HOSPITAL AND EXPIRED. PATIENT OUTCOME: THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100168 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527178

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Death