BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 20300747 · Received September 25, 2024

    Report

    Report Number
    9612515-2024-00068
    Event Type
    Death
    Date Received
    September 25, 2024
    Report Date
    October 24, 2024
    Manufacturer
    VASCUTEK LTD
    Product Code
    QSK
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 2422- OBSTRUCTION/OCCLUSION: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. 2654- THROMBOEMBOLISM: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. IMPACT CODE: 1802- DEATH: AS REPORTED ON EVENT INTAKE THE PATIENT DIED, DATE OF DEATH IS UNKNOWN. MEDICAL DEVICE PROBLEM: 2423- OBSTRUCTION OF FLOW: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. 2654- THROMBOEMBOLISM: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. COMPONENT CODE: 4755- PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110- TREND ANALYSIS: 4 - YEAR REVIEW WAS PERFORMED WHICH GAVE AN OCCURRENCE RATE OF 0.142%, A NEGATIVE TREND WAS IDENTIFIED REQUIRING ACTION AT THIS TIME. 4111- COMMUNICATION/INTERVIEW: ADDITIONAL INFORMATION WAS RECEIVED ON 03 OCT 24 WHICH CONFIRMED THE BELOW. TEVAR (UNDERSTOOD TO BE THORACIC ENDOVASCULAR AORTIC REPAIR) WAS PLANNED TO BE PERFORMED AFTER THE PROCEDURE. SCANS ARE NOT AVAILABLE FOR REVIEW. THERE WAS A THROMBUS NEAR THE SUBCLAVIAN ARTERY, TAR (UNDERSTOOD TO BE TRANSVERSUS ABDOMINIS RELEASE) WAS SELECTED BECAUSE TEVAR (UNDERSTOOD TO BE THORACIC ENDOVASCULAR AORTIC REPAIR) MAY CAUSE THE THROMBUS TO TRAVEL. IT IS UNKNOWN IF THE DEVICE WAS TWISTED OR KINKED BEFORE USE, IF THERE WAS ANY DIFFICULTIES DURING ORIGINAL PROCEDURE, IF THE DEVICE ACHIEVED A COMPLETE SEAL, IF THE PATIENT HAD AND PREVIOUS CLOTTING DISORDER AND HOW LONG AFTER IMPLANT THE OCCLUSION OCCURRED. 3331- ANALYSIS OF PRODUCTION RECORDS: COMPREHENSIVE BATCH REVIEW WAS PERFORMED, NO ISSUES IDENTIFIED DURING THE MANUFACTURE OF THIS DEVICE. NO CAUSAL LINK BETWEEN THE DEVICE AND THE EVENT. 4117- DEVICE NOT ACCESSIBLE FOR TESTING: AS REPORTED THE DEVICE REMAINS IMPLANTED. INVESTIGATION FINDINGS: 3221 - NO FINDINGS AVAILABLE: DUE SCANS NOT BEING MADE AVAILABLE, THE DEVICE NOT BEING AVAILABLE FOR RETURN AN INSPECTION OF THE DEVICE COULD NOT BE PERFORMED AND A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. INVESTIGATION CONCLUSION: 4315 - CAUSE NOT ESTABLISHED: DUE SCANS NOT BEING MADE AVAILABLE, THE DEVICE NOT BEING AVAILABLE FOR RETURN AN INSPECTION OF THE DEVICE COULD NOT BE PERFORMED AND A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 2422- OBSTRUCTION/OCCLUSION: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. 2654- THROMBOEMBOLISM: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. IMPACT CODE: 1802- DEATH: AS REPORTED ON EVENT INTAKE THE PATIENT DIED, DATE OF DEATH IS UNKNOWN. MEDICAL DEVICE PROBLEM: 2423- OBSTRUCTION OF FLOW: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. 2654- THROMBOEMBOLISM: AS REPORTED IN EVENT INTAKE FORM THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED AND CAUSED OCCLUSION DUE TO THE DEVICE IMPLANTATION. COMPONENT CODE: 4755- PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE TYPE OF INVESTIGATION: 4110- TREND ANALYSIS: 4 - YEAR REVIEW WAS PERFORMED WHICH GAVE AN OCCURRENCE RATE OF (B)(4)%, A NEGATIVE TREND WAS IDENTIFIED REQUIRING ACTION AT THIS TIME. 4111- COMMUNICATION/INTERVIEW: AWAITING FURTHER INFORMATION FROM SITE 3331- ANALYSIS OF PRODUCTION RECORDS: COMPREHENSIVE BATCH REVIEW WAS PERFORMED, NO ISSUES IDENTIFIED DURING THE MANUFACTURE OF THIS DEVICE. NO CAUSAL LINK BETWEEN THE DEVICE AND THE EVENT. 4117- DEVICE NOT ACCESSIBLE FOR TESTING: AS REPORTED THE DEVICE REMAINS IMPLANTED. INVESTIGATION FINDINGS. 3233- RESULT PENDING COMPLETION OF INVESTIGATION: INVESTIGATION CONCLUSION. 11- CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    EVENT DATE: UNKNOWN. IMPLANT DATE: (B)(6) 2024. SUSPECTED OCCLUSION DUE TO A THROMBUS TRAVELLED BY DEVICE IMPLANTATION: THE PATIENT WHO HAD THE THORAFLEX HYBRID IMPLANTED ON (B)(6) 2024 DIED. THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED DUE TO THE DEVICE IMPLANTATION AND CAUSED OCCLUSION. IT IS UNKNOWN WHETHER THE OCCLUSION OCCURRED IN THE HEAD OR NOT. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. DURING INSERTION OF THE DELIVERY SYSTEM, THE COLLAR ON THE GREATER CURVATURE SIDE WAS INSERTED DEEPLY INTO THE DISTAL REGION, AND THE STENTED GRAFT SECTION GOT KINKED BY BEING PULLED AND REPOSITIONED. THE OCCURRENCE OF THE KINK IS NOT RELATED TO THE THROMBUS BEING TRAVELLED. CAUSE OF DEATH: POSSIBILITY OF THROMBOTIC OCCLUSION EVENT WAS MARKED AS POSSIBLY RELATED TO: DEVICE / PROCEDURE & PRE-EXISTING CONDITION. NO SURGICAL INTERVENTION WAS PERFORMED. EVENT DATE AND DATE OF DEATH IS UNKNOWN AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP 1 FOR MANUFACTURING REPORT # 9612515-2024-00068 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0040.

    Description of Event or Problem · 0

    EVENT DATE: UNKNOWN. IMPLANT DATE: (B)(6) 2024. SUSPECTED OCCLUSION DUE TO A THROMBUS TRAVELLED BY DEVICE IMPLANTATION: THE PATIENT WHO HAD THE THORAFLEX HYBRID IMPLANTED ON (B)(6) 2024 DIED. THERE IS A POSSIBILITY THAT A THROMBUS MAY HAVE TRAVELLED DUE TO THE DEVICE IMPLANTATION AND CAUSED OCCLUSION. IT IS UNKNOWN WHETHER THE OCCLUSION OCCURRED IN THE HEAD OR NOT. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. DURING INSERTION OF THE DELIVERY SYSTEM, THE COLLAR ON THE GREATER CURVATURE SIDE WAS INSERTED DEEPLY INTO THE DISTAL REGION, AND THE STENTED GRAFT SECTION GOT KINKED BY BEING PULLED AND REPOSITIONED. THE OCCURRENCE OF THE KINK IS NOT RELATED TO THE THROMBUS BEING TRAVELLED CAUSE OF DEATH: POSSIBILITY OF THROMBOTIC OCCLUSION EVENT WAS MARKED AS POSSIBLY RELATED TO: DEVICE / PROCEDURE & PRE-EXISTING CONDITION. NO SURGICAL INTERVENTION WAS PERFORMED EVENT DATE AND DATE OF DEATH IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165566 THORAFLEX HYBRID THORAFLEX HYBRID PLEXUS QSK VASCUTEK LTD N/A 25782848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death