BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6313662 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00378
    Event Type
    Death
    Date Received
    February 9, 2017
    Date of Event
    October 7, 2015
    Report Date
    December 3, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002443256
    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). EVENT IS NO LONGER REPORTABLE IN US AS THE RE-RUPTURE HAPPENED BEFORE THE DEVICE WAS INTRODUCED INTO THE PATIENT AND THEREFORE NO LONGER REASONABLY SUGGESTS THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO "PATIENT'S" DEATH. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT IS REOPENED DUE TO AN ELABORATION OF THE EXSISTING INFORMATION FOR THE EVENT AT 23:30. THE INFORMATION SUPPORTS PREVIOUS STATEMENTS FROM THE COMPANY REPRESENTATIVE AND THE PHYSICIAN, CONFIRMING THAT "THE DEVICE DID NOT CONTRIBUTE TO THE EVENT" AND "THE EVENT WAS CAUSED BY RERUPTURE AND NOT RELATED TO THE DEVICE" AND ARE ALREADY ADDRESSED IN THE PREVIOUSLY PERFORMED INVESTIGATION. INVESTIGATIONAL FINDINGS FROM 23DEC2015: AS NO PRODUCT, PHOTOS OR IMAGING RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. NOTHING INDICATES DEVICE FAILURE OR THAT THE DEVICE WAS NOT ADVANCED ACCORDING TO INSTRUCTIONS.THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT CAN PERHAPS BE RELATED TO THE PATIENTS¿ CONDITION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THE INFORMATION BELOW WAS UPDATED WITH CORRECT INFORMATION ON 09NOV2018. FROM: 23:30: PATIENT'S CONDITION BECAME STABLE ONCE THOUGH, RERUPTURE OCCURRED AT THE SAME TIME WHEN TX-D'S DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT. THE RERUPTURE RESULTED IN SEVERE DROP IN BLOOD PRESSURE, THEN CARDIAC MASSAGE WITH A DEFIBRILLATOR WAS PERFORMED. THE TX-D WAS DEPLOYED AND PLACED TO SEAL THE ENTRY NEAR THE LEFT SA. TO: 23:30: PATIENT CONDITION BECAME STABLE, SO THE PHYSICIAN INSERTED THE WIRE GUIDE INTO THE PATIENT. FOLLOWING THE WIRE GUIDE INSERTION, THE PHYSICIAN ATTEMPTED TO INSERT THE TX-D DELIVERY SYSTEM. HOWEVER JUST BEFORE THE DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT (BEFORE PATIENT CONTACT), THE RE-RUPTURE OCCURRED. WHILE PERFORMING THE CARDIAC MASSAGE, PHYSICIAN INSERTED THE DELIVERY SYSTEM INTO THE PATIENT AND DEPLOY THE TX-D STENT GRAFT TO SEAL THE ENTRY NEAR THE LEFT SA. AS THE PHYSICIAN INITIALLY PLANNED, PATIENT THEN CONVERTED TO THE OPEN SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AS NO PRODUCT, PHOTOS OR IMAGES RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. NOTHING INDICATES DEVICE FAILURE OR THAT THE DEVICE WAS NOT ADVANCED ACCORDING TO INSTRUCTIONS. THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT CAN PERHAPS BE RELATED TO THE PATIENT¿S CONDITION. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. 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) 2015: AT 21:30: THE HOSPITAL RECEIVED THE INFORMATION OF THE PATIENT. AT UNKNOWN TIME: THE PATIENT IN SHOCK WAS TRANSPORTED TO THE HOSPITAL DUE TO RUPTURE OF TYPE B AORTIC DISSECTION NEAR THE DIAPHRAGM. THE EXTENT OF DISSECTION WAS FROM BELOW THE LEFT SA TO BOTH RIGHT AND LEFT EIAS AS FAR AS THE PHYSICIAN COULD CONFIRM. AT 23:00: AN EMERGENCY TEVAR WITH THE TX-D STARTED BY LEFT APPROACH TO TREAT RUPTURED TYPE B AORTIC DISSECTION AND TO SAVE THE PATIENT'S LIFE. AT 23:30: PATIENT'S CONDITION BECAME STABLE ONCE THOUGH, RERUPTURE OCCURRED AT THE SAME TIME WHEN TX-D'S DELIVERY SYSTEM WAS INSERTED INTO THE PATIENT. THE RERUPTURE RESULTED IN SEVERE DROP IN BLOOD PRESSURE, THEN CARDIAC MASSAGE WITH A DEFIBRILLATOR WAS PERFORMED. THE TX-D WAS DEPLOYED AND PLACED TO SEAL THE ENTRY NEAR THE LEFT SA. ON (B)(6) 2015: AT 0:00: SINCE HEMORRHAGE COULD NOT BE CONTROLLED WITH THE DEVICE, THE PHYSICIAN CONVERTED TO OPEN SURGERY FOR BLOOD VESSEL PROTHESIS IMPLANTATION. AT UNKNOWN TIME AFTER 3:00, THE PATIENT DIED IN THE ICU. THE CAUSE OF THE DEATH IS HEMORRHAGIC SHOCK DUE TO RUPTURE OF TYPE B AORTIC DISSECTION. AUTOSY WAS NOT CONDUCTED SINCE HIS FAMILY DID NOT REQUEST IT. PATIENT OUTCOME: THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100166 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3304811 10827002443256

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death