BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT

    MDR report key: 7295478 · Received February 26, 2018

    Report

    Report Number
    3002808486-2018-00272
    Event Type
    Death
    Date Received
    February 26, 2018
    Date of Event
    December 8, 2017
    Report Date
    February 26, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT CONCERNS A PATIENT WITH TAA AND TAAA WHO UNDERWENT TAAA REPAIR. TAA WAS LOCATED IN THE RIGHT BELOW THE LSA IN THE THORACIC ASCENDING AORTA AND TAAA WAS IN THE DESCENDING AORTA. DISTAL TYPE I ENDOLEAK WAS OBSERVED BUT THE PHYSICIAN DETERMINED IT WOULD BE GONE AFTER ANTICOAGULATION WAS NEUTRALIZED AND COMPLETED THE PROCEDURE. AS PER DESCRIPTION OF EVENT, THE ENDOLEAK WAS GONE AND PATIENT DEATH WAS REPORTED TWO DAYS POST-IMPLANTATION AND THE CAUSE WAS ASSUMED TO BE TAA RUPTURE. NO PROCEDURAL IMAGING WAS PROVIDED TO ASSIST WITH THE INVESTIGATION AND NO INFORMATION REGARDING THE ANATOMY OF THE PATIENT WAS PROVIDED. THE ROOT CAUSE CAN THEREFORE NOT BE DETERMINED. AS PER IFU ENDOLEAK AND RUPTURE ARE BOTH KNOWN AS POTENTIAL ADVERSE EVENTS. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2017: A MALE PATIENT WITH TAA AND TAAA UNDERWENT TAAA REPAIR. TAA LOCATED IN THE RIGHT BELOW THE LSA IN THE THORACIC ASCENDING AORTA AND TAAA WAS IN THE DESCENDING AORTA. THE PHYSICIAN DETERMINED THAT THE PATIENT WOULD NOT TOLERATE THE OPERATION FOR DEBRANCHING WHICH WAS REQUIRED TO TREAT TAA, SO THIS PROCEDURE WAS CONDUCTED TO TREAT ONLY TAAA. THE PATIENT HAD VENTRICULAR TACHYCARDIA RIGHT AFTER INDUCTION OF ANESTHESIA AND RESUSCITATED BY CARDIAC MASSAGE. THEN ZTEG-2P-34-152-PF AND ZTEG-2D-38-186-PF WERE PLACED. DISTAL TYPE I ENDOLEAK WAS OBSERVED BUT THE PHYSICIAN DETERMINED IT WOULD BE GONE AFTER ANTICOAGULATION WAS NEUTRALIZED AND COMPLETED THE PROCEDURE. ON (B)(6) 2017: THE PATIENT'S CONDITION SUDDENLY CHANGED AND DECEASED. HE OBSERVED HEMATOTHORAX AND ASSUMED THAT THE CAUSE COULD BE TAA RUPTURE. ADDITIONAL INFORMATION PROVIDED ON 22DEC2017: THE PATIENT WAS (B)(6) YEARS OLD AND HAD RENAL FAILURE AND ICD HAS BEEN IMPLANTED. ON (B)(6) 2017, ON THE DAY FOLLOWING THE IMPLANTATION: PARAPLEGIA IN THE LEFT LOWER LEG AND MINOR REDUCED SENSORY PERCEPTION WERE CONFIRMED. NALOXONE WAS ADMINISTERED. THERE WAS THE ADAMKIEXICZ ARTERY AT THE AREA WHERE THE STENT GRAFT WAS PLACED. SO THE PHYSICIAN DETERMINED THAT PARAPLEGIA WAS NOT OCCURRED BECAUSE THERE WAS A BLOOD FLOW DUE TO DISTAL TYPE I ENDOLEAK AND IT OCCURED AFTER DISTAL TYPE I ENDOLEAK WAS GONE. ON (B)(6) 2017: IN THE MORNING, PARAPLEGIA IN THE LEFT LOWER LEG AND MINOR REDUCED SENSORY PERCEPTION BECAME WORSE, SO DRAINAGE WAS PERFORMED. IN THE AFTERNOON, THE PATIENT LOST CONSCIOUSNESS DURING TALKING WITH HIS FAMILY AND HAD VENTRICULAR FIBRILLATION, THEN HE DECEASED. - AUTOPSY WAS NOT CONDUCTED. PATIENT OUTCOME: PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138751 ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526751

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death