BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 19772871 · Received July 18, 2024

    Report

    Report Number
    9612515-2024-00050
    Event Type
    Death
    Date Received
    July 18, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 12, 2024
    Manufacturer
    VASCUTEK LTD.
    Product Code
    QSK
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: CLINICAL CODE: 1888 - HAEMORRHAGE/ BLEEDING - EVENT REPORTED AS LEAKAGE. IMPACT CODE: 1802- DEATH - PATIENT PASSED AWAY, DATE AND CAUSE OF DEATH ARE UNKNOWN AND HAVE BEEN REQUESTED. DEVICE PROBLEM CODE: 3190 - INSUFFICIENT INFORMATION - NO DEVICE FAILURE /DEFICIENCY HAS BEEN REPORTED. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX LEAKAGE (ALL TYPES) V THORAFLEX SALES JAN 20 - JUL 24 GAVE AN OCCURRENCE RATE OF (B)(4). ACTIONS WILL BE TAKEN ON THIS TREND. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE. 4117 - DEVICE NOT RETURNED: EVENT INTAKE INDICATED DEVICE IS NOT AVAILABLE TO BE RETURNED , CLARIFICATION ON DISPOSITION HAS BEEN REQUESTED. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSION: 11 - CONCLUSION NOT YET AVAILABLE AS INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION: SECTION H1 - THIS WAS REPORTED AS LEAKAGE WITH PATIENT OUTCOME AS DEATH, FURTHER INFORMATION WITH REGARDS TO GELATIN COATING, PATIENT ACT (ACTIVATED CLOTTING TIME) OR APTT ( ACTIVATED PARTIAL THROMBOPLASTIN TIME) SCORE, BLOOD LOSS, AND BLOOD LOSS AFTER HEPARIN REVERSED, GRAFT PRE-SOAKING , LENGTH OF PRE-SOAK, IF THE GRAFT WAS ALLOWED TO DRY, DAMAGE TO GEL COATING, LENGTH OF PROCEDURE, AREA OF LEAKAGE, DEVICE LOCATION, SCANS FOR REVIEW, DATE AND CAUSE OF DEATH WAS REQUESTED ON 15 JUL 2024.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: CLINICAL CODE: 1888 - HAEMORRHAGE/ BLEEDING - EVENT REPORTED AS LEAKAGE .4440 THROMBUS - FLOATING THROMBUS WAS REPORTED. IMPACT CODE: 1802- DEATH - PATIENT PASSED AWAY ON (B)(6) 2024 AS A RESULT OF BOWEL ISCHAEMIE DUE TO FLOATING TROMBUS. DEVICE PROBLEM CODE : 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM - LEAKAGE FROM THE COLLAR ARE OF THE DEVICE. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX LEAKAGE (ALL TYPES) V THORAFLEX SALES JAN 2020 - JUL 2024 GAVE AN OCCURRENCE RATE OF (B)(4). ACTIONS WILL BE TAKEN ON THIS TREND. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE. 4117 - DEVICE NOT RETURNED: DEVICE REMAINED IMPLANTED IN THE PATIENT. 4112 - SCANS WERE RECEIVED AND REVIEWED. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - REVIEW OF ALL RETAINED MANUFACTURING RECORDS FROM BASE FABRIC TO FINISHED PRODUCT SHOWED THE GRAFT WAS MANUFACTURED TO SPECIFICATION AND THE SCAN REVIEW COULD FIND INVESTIGATION CONCLUSION: 4315 - NO CAUSAL LINK BETWEEN THE EVENT AND DEVICE DEFICIENCY COULD BE ESTABLISHED. ADDITIONAL INFORMATION: ADDED DATE OF DEATH IN SECTION B2. SCAN REVIEW PERFORMED BY GLOBAL CLINICAL CASE STUDY MANAGER CONCLUDED THE THORAFLEX HYBRID DEVICE WAS IMPLANTED TO TREAT AN ANEURYSMAL ABERRANT RIGHT SUBCLAVIAN ARTERY. POST OP IMAGING DEMONSTRATES A SUITABLE PROXIMAL ANASTOMOSIS IN THE ASCENDING AORTA, RECONSTRUCTION OF THE ARCH VESSELS AND DISTAL SEALING WITHIN THE THORACIC AORTA. THE EVENT INTAKE FORM INDICATED A POSSIBLE DEVICE FAILURE DUE TO LEAKAGE. ASSESSMENT OF THE IMAGING DID NOT IDENTIFY ANY OBVIOUS LEAKS FROM THE DEVICE, WHICH APPEARS TO BE PERFORMING AS INTENDED.

    Description of Event or Problem · 0

    EVENT REPORTED AS THORAFLEX HYBRID GRAFT IMPLANTED IN 66 YEAR OLD PATIENT (B)(6) 2024 AT (B)(6) EVENT REPORTED AS GRAFT LEAKAGE - PATIENT OUTCOME REPORTED AS PATIENT DEATH. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 0

    EVENT REPORTED AS THORAFLEX HYBRID GRAFT IMPLANTED IN 66 YEAR OLD PATIENT (B)(6) 2024 AT RADBOUD UMC EVENT REPORTED AS GRAFT LEAKAGE - PATIENT OUTCOME REPORTED AS PATIENT DEATH . NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT 9612515-2024-00050 TO PROVIDE ADDITIONAL INFORMATION AND EVENT CLOSURE INFORMATION FOR COMP 5386.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919208 THORAFLEX HYBRID THORAFLEX HYBRID PLEXUS QSK VASCUTEK LTD. THP3034X150B 25046585

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Death