BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 5768515 · Received July 5, 2016

    Report

    Report Number
    3002808486-2016-00668
    Event Type
    Death
    Date Received
    July 5, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 13, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002443218
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT WEIGHT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DEVICE IS SIMILAR TO DEVICE WITH 510(K) P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON IMAGING, IT WAS POSSIBLE TO CONFIRM THE EXISTENCE OF A NEW DISSECTION WITH A NEW FALSE LUMEN WHICH LIKELY DEVELOPED AND RUPTURED WITHIN 2 DAYS OF ENDOGRAFT IMPLANTATION. THE NEW FALSE LUMEN COMPRESSED THE NEARLY THROMBOSED CHRONIC FALSE LUMEN WHICH WAS SUPPLIED THROUGH THE NEW DEVELOPED ENTRY LOCATED AT THE TRANSITION BETWEEN THE ENDOGRAFT AND DISSECTION STENT. UNFORTUNATELY, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS OCCURRENCE, HOWEVER; THE MOST LIKELY ROOT CAUSE MAY BE RELATED TO PATIENT CONDITION SINCE THE DISTAL SEALING ZONE WAS CHRONICALLY OVOID. ADDITIONALLY, THE ORIGINAL DISSECTION WAS LIKELY VERY CHRONIC GIVEN THE INTIMAL FLAP THICKNESS (2MM THICK), THE REMOTE ASCENDING AND ARCH TEAR, AND THE DISSECTION STENT¿S INABILITY TO REMODEL THE TRUE LUMEN. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURE ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS SIMILAR TO DEVICE WITH 510(K) P070016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: UNKNOWN DATE: A FEMALE PATIENT WHO WAS (B)(6) WHEN THE EVENT OCCURRED HAD UNDERGONE TOTAL ARCH REPLACEMENT (TAR) WITH ELEPHANT TRUNK TECHNIQUE ( ET) FOR STANFORD TYPE A DISSECTION. ON (B)(6) 2016: TEVAR WITH ZTEG-2PT-34-197-PF-D/ (B)(4) AND GZSD-36-164-2/ (B)(4) WAS CONDUCTED BY RIGHT APPROACH TO CLOSE THE ENTRY OF THE CHRONIC TYPE B AORTIC DISSECTION AFTER PREVIOUS TAR + ET. (ZTEG- WAS PLACED FIRST, THEN GZSD- WAS PLACED.) DIAMETER OF THE ACCESS ROUTE, THE RIGHT FA, WAS 8MM. THE PATIENT WAS NOT SUITABLE FOR THE TEVAR BECAUSE THE PURPOSE WAS TO TREAT THE CHRONIC TYPE B AORTIC DISSECTION THOUGH, THE PROCEDURE WAS CONDUCTED BECAUSE COOK HAD APPROPRIATE SIZED DEVICES FOR THE TREATMENT. SINCE THE PHYSICIAN THOUGHT THAT THE BLOOD FLOW INTO THE FALSE LUMEN WOULD REMAIN DUE TO A FLOW FROM THE RE-ENTRY DUE TO CHRONIC TYPE 3A DISSECTION, THE BARE STENT WAS PLACED IN HOPES OF SECURING THE TRUE LUMEN AND PROMOTING THROMBUS FORMATION OF THE FALSE LUMEN. BALLOONING WAS NOT PERFORMED IN THE BARE STENT BUT PERFORMED IN THE ARTIFICIAL VESSEL (TAR + ET) AND LANDING ZONE OF THE ZTEG-. FAVORABLE OUTCOME AFTER SURGERY; THE PATIENT HAS WEANED FROM VENTILATOR AT OPERATION ROOM, THEN RETURNED TO ICU. ON (B)(6) 2016 TILL AFTERNOON: THE PATIENT¿S CONDITION WAS STABLE AND SHE WAS ABLE TO WALK WITHOUT ASSISTANCE. EMERGENCY CONTACT TO THE PHYSICIAN WAS MADE DUE TO SUDDEN CHANGES OF THE PATIENT¿S CONDITIONS; UPPER-LIMB PULSES COULD NOT BE FELT. AT LOWER LIMB, DORSAL PEDIS ARTERY WAS PALPABLE. WHEN CT ANGIO WAS BEING PERFORMED FOR EXAMINATION, FALSE LUMEN RUPTURED. THE BLOOD PRESSURE DID NOT RECOVER. THEREFORE RESUSCITATION WAS DIFFICULT AND THE PATIENT DIED. ADDITIONAL INFORMATION PROVIDED ON 17/JUN/2016. RUPTURE WAS CONFIRMED BY PLANE CT, AND SINCE RUPTURE PROGRESSED VERY QUICKLY AS PROGRESSION WAS SEEN ON ANGIOGRAM CT BETWEEN ARTERIAL PHASE AND VENOUS PHASE, THEREFORE, IT WAS IMPOSSIBLE TO TREAT WITH BLOOD TRANSFUSION/INFUSION ETC. PATIENT OUTCOME: ON (B)(6) 2016: THE PATIENT DIED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: UNKNOWN DATE: A FEMALE PATIENT WHO WAS (B)(6) WHEN THE EVENT OCCURRED HAD UNDERGONE TOTAL ARCH REPLACEMENT (TAR) WITH ELEPHANT TRUNK TECHNIQUE ( ET) FOR STANFORD TYPE A DISSECTION. ON (B)(6) 2016: TEVAR WITH ZTEG-2PT-34-197-PF-D/ (B)(4) AND GZSD-36-164-2/ (B)(4) WAS CONDUCTED BY RIGHT APPROACH TO CLOSE THE ENTRY OF THE CHRONIC TYPE B AORTIC DISSECTION AFTER PREVIOUS TAR + ET. (ZTEG- WAS PLACED FIRST, THEN GZSD- WAS PLACED.) DIAMETER OF THE ACCESS ROUTE, THE RIGHT FA, WAS 8MM. THE PATIENT WAS NOT SUITABLE FOR THE TEVAR BECAUSE THE PURPOSE WAS TO TREAT THE CHRONIC TYPE B AORTIC DISSECTION THOUGH, THE PROCEDURE WAS CONDUCTED BECAUSE COOK HAD APPROPRIATE SIZED DEVICES FOR THE TREATMENT. SINCE THE PHYSICIAN THOUGHT THAT THE BLOOD FLOW INTO THE FALSE LUMEN WOULD REMAIN DUE TO A FLOW FROM THE RE-ENTRY DUE TO CHRONIC TYPE 3A DISSECTION, THE BARE STENT WAS PLACED IN HOPES OF SECURING THE TRUE LUMEN AND PROMOTING THROMBUS FORMATION OF THE FALSE LUMEN. BALLOONING WAS NOT PERFORMED IN THE BARE STENT BUT PERFORMED IN THE ARTIFICIAL VESSEL (TAR + ET) AND LANDING ZONE OF THE ZTEG-. FAVORABLE OUTCOME AFTER SURGERY; THE PATIENT HAS WEANED FROM VENTILATOR AT OPERATION ROOM, THEN RETURNED TO ICU. ON (B)(6) 2016 TILL AFTERNOON: THE PATIENT'S CONDITION WAS STABLE AND SHE WAS ABLE TO WALK WITHOUT ASSISTANCE. EMERGENCY CONTACT TO THE PHYSICIAN WAS MADE DUE TO SUDDEN CHANGES OF THE PATIENT'S CONDITIONS; UPPER-LIMB PULSES COULD NOT BE FELT. AT LOWER LIMB, DORSAL PEDIS ARTERY WAS PALPABLE. WHEN CT ANGIO WAS BEING PERFORMED FOR EXAMINATION, FALSE LUMEN RUPTURED. THE BLOOD PRESSURE DID NOT RECOVER. THEREFORE RESUSCITATION WAS DIFFICULT AND THE PATIENT DIED. ADDITIONAL INFORMATION PROVIDED ON 17/JUN/2016: RUPTURE WAS CONFIRMED BY PLANE CT, AND SINCE RUPTURE PROGRESSED VERY QUICKLY AS PROGRESSION WAS SEEN ON ANGIOGRAM CT BETWEEN ARTERIAL PHASE AND VENOUS PHASE, THEREFORE, IT WAS IMPOSSIBLE TO TREAT WITH BLOOD TRANSFUSION/INFUSION ETC. PATIENT OUTCOME: ON (B)(6) 2016: THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422798 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002443218

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death