BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 17547650 · Received August 15, 2023

    Report

    Report Number
    9612515-2023-00012
    Event Type
    Death
    Date Received
    August 15, 2023
    Date of Event
    April 25, 2020
    Report Date
    August 29, 2023
    Manufacturer
    VASCUTEK LTD.
    Product Code
    QSK
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 UPDATED WITH ADDITIONAL INFORMATION. CLINICAL CODE: 4580 INSUFFICIENT INFORMATION: THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL TO HOSPITAL, AND AN AUTOPSY WAS NOT PERFORMED. IMPACT CODE: 1802 DEATH: PATIENT OUTCOME WAS DEATH, REASON FOR THIS IS STILL UNKNOWN 4648 INSUFFICIENT INFORMATION: THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL TO HOSPITAL, AND AN AUTOPSY WAS NOT PERFORMED. MEDICAL DEVICE PROBLEM CODE: 3190 INSUFFICIENT INFORMATION: THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL TO HOSPITAL, AND AN AUTOPSY WAS NOT PERFORMED. THERE IS NO DIRECT ALLEGATION AGAINST THE DEVICE, BUT AGAIN, THERE'S NO INFORMATION AVAILABLE FOR/AGAINST DEVICE RELATIONSHIP. TYPE OF INVESTIGATION: 4110 TREND ANALYSIS: A SIMILAR EVENT REVIEW WAS PERFORMED FOR THIS EVENT WHICH GAVE AN OCCURRENCE RATE OF 0.079%. NO NEGATIVE TREND IDENTIFIED. 3331 ANALYSIS OF PRODUCTION RECORD: A REVIEW OF THE BATCH RECORDS CONFIRM THAT DEVICE WAS MANUFACTURED TO SPECIFICATION. 4119 INSUFFICIENT INFORMATION: THE PATIENT WAS PRONOUNCED DECEASED ON ARRIVAL TO HOSPITAL, AND AN AUTOPSY WAS NOT PERFORMED. INVESTIGATION FINDINGS: 3221 NO FINDINGS AVAILABLE: NO AUTOPSY WAS DONE, AND WE THEREFORE DO NOT HAVE ANY SAMPLES AVAILABLE. INVESTIGATION CONCLUSION: 4315 CAUSE NOT ESTABLISHED: NO ROOT CAUSE IDENTIFIED FOR THIS EVENT DUE TO A LACK OF INFORMATION. THERE IS NO DIRECT ALLEGATION AGAINST THE DEVICE, BUT AGAIN, THERE'S NO INFORMATION AVAILABLE FOR/AGAINST DEVICE RELATIONSHIP. COMPONENT CODE: 4755 PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 4580 INSUFFICIENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SITE. IMPACT CODE 1802 DEATH: PATIENT OUTCOME WAS DEATH, REASON FOR THIS IS STILL UNKNOWN 4648 INSUFFICIENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SITE. MEDICAL DEVICE PROBLEM CODE 3190 INSUFFICIENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SITE. TYPE OF INVESTIGATION 4110 TREND ANALYSIS: A SIMILAR EVENT REVIEW WAS PERFORMED FOR THIS EVENT WHICH GAVE AN OCCURRENCE RATE OF 0.079%. NO NEGATIVE TREND IDENTIFIED 3331 ANALYSIS OF PRODUCTION RECORD: A REVIEW OF THE BATCH RECORDS CONFIRM THAT DEVICE WAS MANUFACTURED TO SPECIFICATION. 4119 INSUFFICIENT INFORMATION: ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM SITE.

    Description of Event or Problem · 0

    AS REPORTED THOR EVENT. STUDY TEAM HAS BEEN INFORMED PATIENT DIED IN (B)(6) 2020. NO AUTOPSY DONE. FURTHER INFORMATION HAS BEEN REQUESTED, WILL UPDATE SAE CRF ONCE AVAILABLE. CAUSE OF DEATH IS UNKNOWN. NO SOURCE AVAILABLE, ""POSSIBLY RELATED"" ENTERED AS DEFINITIVE ASSESSMENT CANNOT BE PERFORMED. *TEXT ABOVE STATING MAY, EVENT DATE IN CRF 25-APR-2020" THIS REPORT IS BEING SUBMITTED AS FINAL REPORT FOR MFG. REPORT TO PROVIDE EVENT CLOSURE INFORMATION FOR COMP (B)(4).

    Description of Event or Problem · 0

    AS REPORTED THOR EVENT STUDY TEAM HAS BEEN INFORMED PATIENT DIED (B)(6) 2020. NO AUTOPSY DONE. FURTHER INFORMATION HAS BEEN REQUESTED, WILL UPDATE SAE CRF ONCE AVAILABLE. CAUSE OF DEATH IS UNKNOWN. NO SOURCE AVAILABLE, ""POSSIBLY RELATED"" ENTERED AS DEFINITIVE ASSESSMENT CANNOT BE PERFORMED. *TEXT ABOVE STATING (B)(6) , EVENT DATE IN CRF (B)(6) 2020".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665456 THORAFLEX HYBRID QSK VASCUTEK LTD. 17600729

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death