BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 22828025 · Received August 18, 2025

    Report

    Report Number
    9612515-2025-00071
    Event Type
    Death
    Date Received
    August 18, 2025
    Date of Event
    October 17, 2024
    Report Date
    October 14, 2025
    Manufacturer
    VASCUTEK LTD
    Product Code
    QSK
    UDI-DI
    05037881026848
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 4580 - INSUFFICIENT INFORMATION: NO INFORMATION PROVIDED REGARDING CLINICAL SIGNS/ SYMPTOMS. IMPACT CODE 1802- DEATH: THE PATIENT HAD DIED ON (B)(6) 2024. MEDICAL DEVICE PROBLEM 3190 - INSUFFICIENT INFORMATION: AWAITING INFORMATION FROM THE SITE. COMPONENT CODE 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION 3331 - ANALYSIS OF PRODUCTION RECORDS: A REVIEW OF THE MANUFACTURING AND QUALITY CONTROL RECORDS FOR THIS BATCH CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. 4110 - TREND ANALYSIS: A 4 YEAR REVIEW WAS PERFORMED FOR THORAFLEX HYBRID > MEDICAL EVENT > DEATH THIS GAVE AN OCCURRENCE RATE OF LESS THAN (B)(4). NO TREND IDENTIFIED THAT REQUIRED ACTION AT THIS TIME 4111 - COMMUNICATION/INTERVIEWS: ADDITIONAL INFORMATION HAS BEEN REQUESTED, WAITING ON INFORMATION FROM THE SITE. 4117 - DEVICE NO ACCESSIBLE FOR TESTING: THE DEVICE REMAINS IMPLANTED. INVESTIGATION FINDINGS 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSION 11 - CONCLUSION NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

    CLINICAL CODE: 3261- MULTIPLE ORGAN DYSFUNCTION SYNDROME- MULTI-SYSTEM ORGAN FAILURE 2422- OBSTRUCTION/ OCCLUSION- BOWEL OBSTRUCTION IMPACT CODE 1802- DEATH: THE PATIENT HAD DIED ON (B)(6) 2024 MEDICAL DEVICE PROBLEM 2992- ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM: IT WAS STATED BY THE PHYSICIAN THAT THE EVENT OF DEATH WAS NOT DEVICE RELATED COMPONENT CODE 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE TYPE OF INVESTIGATION 3331 - ANALYSIS OF PRODUCTION RECORDS: A FULL BATCH REVIEW WAS PERFORMED FOR TAG0292, AND NO ISSUES WERE IDENTIFIED DURING MANUFACTURING PROCESS FROM RAW MATERIALS TO FINISHED PRODUCTS. 4110 - TREND ANALYSIS: A 4 YEAR REVIEW WAS PERFORMED FOR THORAFLEX HYBRID > MEDICAL EVENT > DEATH THIS GAVE AN OCCURRENCE RATE OF LESS THAN 0.069%. NO TREND IDENTIFIED THAT REQUIRED ACTION AT THIS TIME 4111 - COMMUNICATION/INTERVIEWS: ON 07 OCT 25, ADDITIONAL INFORMATION CONFIRMED THAT THE PATIENT DIED FROM MULTI-SYSTEM ORGAN FAILURE RESULTING FROM A BOWEL OBSTRUCTION. 4117 - DEVICE NO ACCESSIBLE FOR TESTING: THE DEVICE REMAINS IMPLANTED INVESTIGATION FINDINGS 213 - NO DEVICE PROBLEM FOUND- ON (B)(6) 2025, ADDITIONAL INFORMATION CONFIRMED THAT THE PATIENT DIED FROM MULTI-SYSTEM ORGAN FAILURE RESULTING FROM A BOWEL OBSTRUCTION. IT WAS STATED BY THE PHYSICIAN THAT THE EVENT OF DEATH WAS NOT DEVICE RELATED, HENCE IT WAS NO LONGER CONSIDERED TO BE A COMPLAINT. INVESTIGATION CONCLUSION 4323 - DEVICE PROBLEM EXCLUDED- ON (B)(6) 2025, ADDITIONAL INFORMATION CONFIRMED THAT THE PATIENT DIED FROM MULTI-SYSTEM ORGAN FAILURE RESULTING FROM A BOWEL OBSTRUCTION. IT WAS STATED BY THE PHYSICIAN THAT THE EVENT OF DEATH WAS NOT DEVICE RELATED, HENCE IT WAS NO LONGER CONSIDERED TO BE A COMPLAINT.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED ON (B)(6) 2024 AND DIED ON (B)(6) 2024. CAUSE OF DEATH IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED ON (B)(6) 2024 AND DIED (B)(6) 2024. CAUSE OF DEATH WAS CONFIRMED RESULTING FROM A BOWEL OBSTRUCTION THIS REPORT IS BEING SUBMITTED AS FINAL FOR MANUFACTURING REPORT NUMBER 9612515-2025-00071 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0292.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679469 THORAFLEX HYBRID THORAFLEX HYBRID PLEXUS QSK VASCUTEK LTD 25018578 05037881026848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death