BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6131490 · Received November 29, 2016

    Report

    Report Number
    3002808486-2016-01456
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 9, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526935
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4) . INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: NO IMAGING WAS PROVIDED AND NO AUTOPSY WAS DONE. BASED ON THE INFORMATION PROVIDED IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE AORTA RUPTURE, WHETHER IT WAS DEVICE RELATED, PROCEDURE RELATED OR RELATED TO THE PATHOLOGICAL CONDITION OF THE PATIENT. IT IS LIKELY THAT THE AORTA RUPTURE HAD OCCURRED BEFORE BRADYCARDIA WAS CONFIRMED DUE TO THE LOW HB. AS PER THE IFU, ANEURYSM RUPTURE, AORTIC DAMAGE, INCLUDING PERFORATION, BLEEDING, RUPTURE AND DEATH ARE KNOWN ADVERSE EVENTS. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURE ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6) 2016: AN (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE TAA WAS LOCATED AT THE DISTAL SIDE OF AORTA ARCH. AT 8:30 AM, THE PROCEDURE WAS STARTED. THE ACCESS VESSEL WAS APPROX. 6MM WITH CALCIFICATION, SO THE DELIVERY SYSTEM WAS INSERTED AND ADVANCED FROM THE COMMON ILIAC ARTERY BY OPENING THE ABDOMEN. AFTER DEPLOYMENT OF THE STENT GRAFT WITH APPROX 50MM OF SEALING AT THE PROXIMAL SIDE, PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED. THE PHYSICIAN PERFORMED ADDITIONAL BALLOONING AT THE PROXIMAL SEALING AND CONFIRMED THE ENDOLEAK WAS SOLVED BY ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED AT AROUND 11:30 AM. 15:30 : THE PATIENT MOVED TO A GENERAL WARD FROM ICU. 16:30 : THE PATIENT COMPLAINED OF AXILLARY PAIN. BUT NO PROBLEMS WERE OBSERVED ABOUT VITAL SIGNS, BLOOD PRESSURE, AMOUNT OF URINE. OXYGEN SATURATION KEPT 100. HB WAS 8.3. 16:45 : CALONAL(ACETAMINOPHEN) WAS ADMINISTERED. 19:00 : THE AXILLARY PAIN WAS GONE. (B)(6) 2016: 02:30 : BRADYCARDIA WAS CONFIRMED. CARDIAC COMPRESSION WAS STARTED. HB WAS 3.1. 02:40 : THE PATIENT SUFFERED A CARDIOPULMONARY ARREST. TRANSFUSION WAS ADMINISTRATED DURING PERFORMING CARDIAC COMPRESSION. 04:15 : HEMOTHORAX WAS CONFIRMED. 2500CC OF HEMORRHAGE WAS CONFIRMED BY THE LEFT CHEST PUNCTURE. HB WAS 7.6. THE FAMILY OF THE PATIENT DIDN'T WANT THORACOTOMY TO TREAT THE CONDITION, AND THE PATIENT DECEASED DUE TO HEMORRHAGE FROM THE AORTA RUPTURE. ADDITIONAL INFORMATION FROM THE PHYSICIAN: THE FAMILY DIDN'T WANT AUTOPSY, SO THE EXACT CAUSE OF THE RUPTURE OF AORTA WAS UNKNOWN. HOWEVER, GIVEN THAT THE SYMPTOM OCCURRED ON THE SAME DAY AS HIS TEVAR, I CAN'T COMPLETELY DENY RELATIONSHIP OF THE DEVICE USED. I THINK THAT THE AORTA RUPTURE WAS MORE POSSIBLE THAN OCCURRENCE AND RUPTURE OF TYPE A DISSECTION BECAUSE AN AORTA LINE CATHETER WHICH WAS INSERTED INTO THE RIGHT ARM WAS WORKING. THE ENDOLEAK WAS GONE AT THE FINAL ANGIO. IN THE FIRST PLACE, OCCURRENCE OF PROXIMAL TYPE I ENDOLEAK WITH 50MM SEALING ZONE WAS UNLIKELY. THERE COULD BE SOMETHING WRONG AT THIS POINT ALREADY. THE AORTA RUPTURE WAS PROBABLY OCCURRED BEFORE BRADYCARDIA WAS CONFIRMED. THE PATIENT'S FAMILY WAS CONVINCED OF THIS RESULT AND NO AUTOPSY WILL BE CONDUCTED. PATIENT OUTCOME: THE PATIENT DECEASED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2016: AN (B)(6) MALE PATIENT UNDERWENT TAA REPAIR. THE TAA WAS LOCATED AT THE DISTAL SIDE OF AORTA ARCH. AT 8:30 AM, THE PROCEDURE WAS STARTED. THE ACCESS VESSEL WAS APPROX. 6MM WITH CALCIFICATION, SO THE DELIVERY SYSTEM WAS INSERTED AND ADVANCED FROM THE COMMON ILIAC ARTERY BY OPENING THE ABDOMEN. AFTER DEPLOYMENT OF THE STENT GRAFT WITH APPROX 50MM OF SEALING AT THE PROXIMAL SIDE, PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED. THE PHYSICIAN PERFORMED ADDITIONAL BALLOONING AT THE PROXIMAL SEALING AND CONFIRMED THE ENDOLEAK WAS SOLVED BY ANGIOGRAPHY. THE PROCEDURE WAS COMPLETED AT AROUND 11:30 AM. 15:30 : THE PATIENT MOVED TO A GENERAL WARD FROM ICU. 16:30 : THE PATIENT COMPLAINED OF AXILLARY PAIN. BUT NO PROBLEMS WERE OBSERVED ABOUT VITAL SIGNS, BLOOD PRESSURE, AMOUNT OF URINE. OXYGEN SATURATION KEPT 100. HB WAS 8.3. 16:45 : CALONAL(ACETAMINOPHEN) WAS ADMINISTERED. 19:00 : THE AXILLARY PAIN WAS GONE. ON (B)(6) 2016: 02:30 : BRADYCARDIA WAS CONFIRMED. CARDIAC COMPRESSION WAS STARTED. HB WAS 3.1. 02:40 : THE PATIENT SUFFERED A CARDIOPULMONARY ARREST. TRANSFUSION WAS ADMINISTRATED DURING PERFORMING CARDIAC COMPRESSION. 04:15 : HEMOTHORAX WAS CONFIRMED. 2500CC OF HEMORRHAGE WAS CONFIRMED BY THE LEFT CHEST PUNCTURE. HB WAS 7.6. THE FAMILY OF THE PATIENT DIDN'T WANT THORACOTOMY TO TREAT THE CONDITION, AND THE PATIENT DECEASED DUE TO HEMORRHAGE FROM THE AORTA RUPTURE. ADDITIONAL INFORMATION FROM THE PHYSICIAN: THE FAMILY DIDN'T WANT AUTOPSY, SO THE EXACT CAUSE OF THE RUPTURE OF AORTA WAS UNKNOWN. HOWEVER, GIVEN THAT THE SYMPTOM OCCURRED ON THE SAME DAY AS HIS TEVAR, I CAN'T COMPLETELY DENY RELATIONSHIP OF THE DEVICE USED. I THINK THAT THE AORTA RUPTURE WAS MORE POSSIBLE THAN OCCURRENCE AND RUPTURE OF TYPE A DISSECTION BECAUSE AN AORTA LINE CATHETER WHICH WAS INSERTED INTO THE RIGHT ARM WAS WORKING. THE ENDOLEAK WAS GONE AT THE FINAL ANGIO. IN THE FIRST PLACE, OCCURRENCE OF PROXIMAL TYPE I ENDOLEAK WITH 50MM SEALING ZONE WAS UNLIKELY. THERE COULD BE SOMETHING WRONG AT THIS POINT ALREADY. THE AORTA RUPTURE WAS PROBABLY OCCURRED BEFORE BRADYCARDIA WAS CONFIRMED. THE PATIENT'S FAMILY WAS CONVINCED OF THIS RESULT AND NO AUTOPSY WILL BE CONDUCTED. PATIENT OUTCOME: THE PATIENT DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783238 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526935

    Patients

    Seq Age Sex Outcome Treatment
    1 81 DA Death