BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID PLEXUS

    MDR report key: 20320258 · Received September 27, 2024

    Report

    Report Number
    9612515-2024-00069
    Event Type
    Death
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2018
    Report Date
    November 26, 2024
    Manufacturer
    VASCUTEK LTD
    Product Code
    QSK
    PMA / PMN Number
    P210006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL CODE (E) 1708: ANEURYSM: THORACIC ANEURYSM 4436: RUPTURED ANEURYSM: ON 17 SEP 23 PATIENT SUFFERED AN ANEURYSM RUPTURE. 1908: HIGH BLOOD PRESSURE/ HYPERTENSION IMPACT CODE (F) 1802: DEATH: ON 17 SEP 23 PATIENT SUFFERED AN ANEURYSM RUPTURE. THIS WAS A SEVERE UNANTICIPATED EVENT THAT SUBSEQUENTLY LED TO DEATH. THIS WAS NOT RELATED TO THE DEVICE OR PROCEDURE AS ASSESSED BY THE CLINICAL STUDY SITE INVESTIGATOR BUT RELATED TO THE PATIENTS PRE-EXISTING CONDITION. THE REPORT IS FOR ENDOLEAK TYPE 1 HOWEVER OUTCOME HAS BEEN DEATH RELATED TO PATIENT CONDITION. MEDICAL DEVICE PROBLEM CODE (A) 4074: ENDOLEAKS: AN ANTICIPATED NEW TYPE 1B ENDOLEAK WAS NOTED COMPONENT CODE (G) 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE: DEVICE HAS NO DISTINCT COMPONENTS TYPE OF INVESTIGATION (B) 4110 - TREND ANALYSIS: A 5 YEAR REVIEW OF SIMILAR COMPLAINTS (ENDOLEAK) GAVE AN OCCURRENCE RATE OF 0.09% (COMPLAINTS VS SALES). NO TREND REQUIRING ACTION WAS IDENTIFIED IN THIS SIMILAR EVENT REVIEW. 4111 - COMMUNICATION/INTERVIEWS: ADDITIONAL INFORMATION WAS REQUESTED ON 30 AUG 24 REGARDING THE PATIENTS STAY WITHIN THE HOSPITAL PROLONGED DUE TO THIS ENDOLEAK, IF ANY FURTHER INTERVENTION PERFORMED TO RESOLVE THE ENDOLEAK BETWEEN 2018 AND 2023, IF THE TYPE 1 ASSOCIATED WITH ANY OTHER DEVICE EVENT - MIGRATION, INTEGRITY FAILURE ETC, IF THERE IS ANY IMAGES/ SCAN/ RETURN AVAILABLE FOR THE DEVICE. 3331 - ANALYSIS OF PRODUCTION RECORDS: A REVIEW OF MANUFACTURING AND QC RECORDS CONFIRMED THAT THERE WERE NO ISSUES WITH THE MANUFACTURE OF THE DEVICE. 4117- DEVICE NOT ACCESSIBLE FOR TESTING: DEVICE REMAINED IMPLANTED INVESTIGATION FINDINGS (C) 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION CONCLUSIONS (D) 11 - CONCLUSION NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

    CLINICAL CODE (E) 1708: ANEURYSM: THORACIC ANEURYSM. 4436: RUPTURED ANEURYSM: ON (B)(6) 2023 PATIENT SUFFERED AN ANEURYSM RUPTURE. 1908: HIGH BLOOD PRESSURE/ HYPERTENSION. IMPACT CODE (F): 1802: DEATH: THIS WAS A SEVERE UNANTICIPATED EVENT THAT SUBSEQUENTLY LEAD TO DEATH. MEDICAL DEVICE PROBLEM CODE (A): 4074: ENDOLEAKS: AN ANTICIPATED NEW TYPE 1B ENDOLEAK WAS NOTED BY THE COMPLAINANT. COMPONENT CODE (G): 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE: DEVICE HAS NO DISTINCT COMPONENTS. TYPE OF INVESTIGATION (B): 4110 - TREND ANALYSIS: A 5 YEAR REVIEW OF SIMILAR COMPLAINTS (ENDOLEAK) GAVE AN OCCURRENCE RATE OF LESS THAN 0.09% (COMPLAINTS VS SALES). NO TREND REQUIRING ACTION WAS IDENTIFIED IN THIS SIMILAR EVENT REVIEW. 4111 - COMMUNICATION/INTERVIEWS: ADDITIONAL INFORMATION WAS REQUESTED ON 30 AUG 2024 REGARDING THE PATIENTS STAY WITHIN THE HOSPITAL PROLONGED DUE TO THIS ENDOLEAK, IF ANY FURTHER INTERVENTION PERFORMED TO RESOLVE THE ENDOLEAK BETWEEN 2018 AND 2023, IF THE TYPE 1 ASSOCIATED WITH ANY OTHER DEVICE EVENT - MIGRATION, INTEGRITY FAILURE ETC, IF THERE IS ANY MAGES/ SCAN/ RETURN AVAILABLE FOR THE DEVICE. 4112 - ANALYSIS OF INFORMATION PROVIDED BY USER/ THIRD PARTY: A REVIEW OF PATIENT SCANS WAS PERFORMED WHICH CONFIRMED THAT THERE WAS NO INTENTION TO CREATE A DISTAL SEAL AND NO EXTENSION PROCEDURE WAS PERFORMED. NO TORTUOUS ANATOMY, DEVICE FAILURE, OR DEVICE MIGRATION WAS OBSERVED. IT CAN THEREFORE BE DETERMINED THAT THE ENDOLEAK WAS ANTICIPATED AND THE ROOT CAUSE OF THIS EVENT IS PROCEDURE / TECHNICAL RELATED. 3331 - ANALYSIS OF PRODUCTION RECORDS: A REVIEW OF MANUFACTURING AND QC RECORDS CONFIRMED THAT THERE WERE NO ISSUES WITH THE MANUFACTURE OF THE DEVICE. 4117- DEVICE NOT ACCESSIBLE FOR TESTING: DEVICE REMAINED IMPLANTED. INVESTIGATION FINDINGS (C): 4248 - USAGE PROBLEM IDENTIFIED: THIS ENDOLEAK TYPE 1B WAS ANTICIPATED AND IS A KNOWN AND EXPECTED COMPLICATION AS PER THE IFU. INVESTIGATION CONCLUSIONS (D). 4311 - ADVERSE EVENT RELATED TO PROCEDURE: PER SCAN REVIEW AND ROOT CAUSE ANALYSIS PERFORMED, THE CAUSE OF THIS EVENT HAS BEEN CONFIRMED TO BE AN ANTICIPATED ENDOLEAK DUE TO THE THORAFLEX HYBRID DEVICE NOT BEING DISTALLY SEALED.

    Description of Event or Problem · 0

    EVENT REPORTED AS PART OF THE THOR STUDY (NCT03414866). PATIENT PRECONDITIONS: THORACIC ANEURYSM, HYPERTENSION CONTROLLED BY MEDICATION. THE PATIENT WAS IMPLANTED WITH A THORAFLEX HYBRID ON 20 AUG 18 FOR TREATMENT OF THORACIC ANEURYSM. COLLAR ATTACHMENT WAS ATTACHED AT ZONE 2, THIS WAS AN URGENT PROCEDURE AND CSF (UNDERSTOOD TO BE CEREBRAL SPINAL FLUID) DRAINAGE WAS IMPLEMENTED POST OPERATIVELY. ON 30 AUG 18 IMAGING WAS PERFORMED, IN THE PERIGRAFT LUMEN THROMBOSIS HAD BEEN NOTED AROUND THE FROZEN ELEPHANT TRUNK. AN ANTICIPATED NEW TYPE 1B ENDOLEAK WAS NOTED AND HAS BEEN HIGHLIGHTED AS POSSIBLY RELATED TO MAIN BODY DEVICE, PROCEDURE & PRE-EXISTING CONDITION. PATIENT SPENT 20 DAYS IN HOSPITAL. ON 17 SEP 23 PATIENT SUFFERED AN ANEURYSM RUPTURE. THIS WAS A SEVERE UNANTICIPATED EVENT THAT SUBSEQUENTLY LED TO DEATH. THIS WAS NOT RELATED TO THE DEVICE OR PROCEDURE AS ASSESSED BY THE CLINICAL STUDY SITE INVESTIGATOR BUT RELATED TO THE PATIENTS PRE-EXISTING CONDITION.

    Description of Event or Problem · 0

    EVENT REPORTED AS PART OF THE THOR STUDY (B)(6). PATIENT PRECONDITIONS: THORACIC ANEURYSM, HYPERTENSION CONTROLLED BY MEDICATION. THE PATIENT WAS IMPLANTED WITH A THORAFLEX HYBRID ON 20 AUG 18 FOR TREATMENT OF THORACIC ANEURYSM. COLLAR ATTACHMENT WAS ATTACHED AT ZONE 2, THIS WAS AN URGENT PROCEDURE AND CSF (UNDERSTOOD TO BE CEREBRAL SPINAL FLUID) DRAINAGE WAS IMPLEMENTED POST OPERATIVELY. ON (B)(6) 2018 IMAGING WAS PERFORMED, IN THE PERIGRAFT LUMEN THROMBOSIS HAD BEEN NOTED AROUND THE FROZEN ELEPHANT TRUNK. AN ANTICIPATED NEW TYPE 1B ENDOLEAK WAS NOTED AND HAS BEEN HIGHLIGHTED AS POSSIBLY RELATED TO MAIN BODY DEVICE, PROCEDURE & PRE-EXISTING CONDITION. PATIENT SPENT 20 DAYS IN HOSPITAL. ON (B)(6) 2023 PATIENT SUFFERED AN ANEURYSM RUPTURE. THIS WAS A SEVERE UNANTICIPATED EVENT THAT SUBSEQUENTLY LEAD TO DEATH. THIS WAS NOT RELATED TO THE DEVICE OR PROCEDURE AS ASSESSED BY THE CLINICAL STUDY SITE INVESTIGATOR BUT RELATED TO THE PATIENTS PRE-EXISTING CONDITION. THIS REPORT IS BEING SUBMITTED AS A FINAL FOR MFG REPORT NUMBER 9612515-2024-00069 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663516 THORAFLEX HYBRID PLEXUS THORAFLEX HYBRID QSK VASCUTEK LTD N/A 17376331

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death| H