BEUDAMED
    FDA Adverse Event Death Summary report: N

    THORAFLEX HYBRID

    MDR report key: 22931644 · Received September 2, 2025

    Report

    Report Number
    9612515-2025-00072
    Event Type
    Death
    Date Received
    September 2, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 23, 2025
    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

    MANUFACTURER NARRATIVE: CLINICAL CODE: 2263 -STENOSIS - STENOSIS REPORTED IN THE STENTED SECTION OF THE THORAFLEX HYBRID DEVICE. 1942 - ISCHEMIA - INTESTINAL ISCHEMIA REPORTED ONSET DATE 07 AUG 25. SYMPTOMS OF INTESTINAL ISCHEMIA WERE CONFIRMED, AND AN EMERGENCY CT SCAN WAS PERFORMED. STENOSIS IN THE STENT GRAFT SECTION WAS CONFIRMED. THIS CAUSED CARDIAC STRESS, LEADING TO CARDIAC DYSFUNCTION. IMPACT CODE: 4624 - SURGICAL INTERVENTION -EMERGENCY STENT GRAFTING WAS PERFORMED. BLOOD PRESSURE WAS MEASURED AT 97/45 IN THE UPPER LIMBS AND AT 72/45 IN THE LOWER LIMBS, INDICATING A PRESSURE DIFFERENCE. IT WAS DIFFICULT TO ADVANCE A PIGTAIL CATHETER ALONE THROUGH THE THORAFLEX HYBRID, SO THE PIGTAIL CATHETER WAS REPLACED WITH A LUNDERQUIST (COOK MEDICAL). THEN A VALIENT (VAMF3636150TJ, MEDTRONIC) WAS INSERTED AND IMPLANTED TO COVER THE STENT GRAFT SECTION OF THE THORAFLEX HYBRID. AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. THE STENOSIS WAS SLIGHTLY IMPROVED. THE PRESSURE DIFFERENCE THE PRESSURE DIFFERENCE WAS ALMOST RESOLVED, AND CARDIAC FUNCTION RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED. 1802 - PATIENT DEATH - ADDITIONAL INFORMATION WAS RECEIVED TO SAY THE PATIENT PASSED AWAY, NO DATE OF DEATH, AUTOPSY INFORMATION OR RECORDED CAUSE OF DEATH HAS BEEN REPORTED TO DATE. DEVICE PROBLEM CODE: 4066 -DEVICE STENOSIS - STENOSIS REPORTED IN THE STENTED SECTION OF THE THORAFLEX HYBRID DEVICE. AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: -THORAFLEX HYBRID SALES JAN 21 - JUL 25 VS THORAFLEX HYBRID STENOSIS EVENTS JAN 21 - AUG 25 HAD AN OCCURRENCE RATE OF (B)(4) NO TREND REQUIRING ACTION HAS BEEN IDENTIFIED. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION RECEIVED TO SAY THE GRAFT WAS NOT CUT USING A CAUTERY , ARTERIES WERE NOT CALCIFIED NO PARTICULATE WAS NOTED ON THE OUTER OR INNER SURFACE OF THE GRAFT DURING IMPLANT , THE GRAFT WAS NOT OVER MANIPULATED FOR A PROCEDURE OF THIS TYPE, THE PATIENT DID NOT HAVE ANU OTHER PRE-EXISTING DEVICES IMPLANTED INTO THEIR VASCULAR SYSTEM , THE PATIENTS ANATOMY DID NOT HAVE HIGH ANGULATION OR TORTUOSITY AND NO ADDITIONAL IMAGING / SCANS ARE AVAILABLE TO REVIEW. NARRATIVE WAS UPDATED TO STATE THE COMPOSITE GRAFT WAS ANASTOMOSED TO THE GRAFT SECTION OF THE DEVICE ( NOT THE STENTED SECTION ) 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW WAS PERFORMED FROM BASE FABRIC TO FINISHED PRODUCT FOR DEVICE ID- 25952361 WHICH CONFIRMED THE DEICE WAS MANUFACTURED TO SPECIFICATION WITH NO ISSUES FOUND. 4117 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - NO ISSUES WERE FOUND WITH THE MANUFACTURE OF THE DEVICE, WITH THE CLARIFICATION OF ATTACHING THE COMPOSITE DEVICE TO THE GRAFT PORTION AND THE DETAILS AND IMAGES RECEIVED, THIS LOOKS LIKE THE STENOSIS WAS AT LEAST IN PART CAUSED BY THE PATIENT'S ANATOMY, INVESTIGATION CONCLUSION: 4315 - CAUSE NOT ESTABLISHED - THERE IS RELATIVELY HIGH ANGULATION OF THE AORTA VISIBLE DIRECTLY AFTER THE ANEURYSM SAC ON THE DRAWING SUPPLIED BY THE CLINICIAN. WHILE THE OVERALL CURVATURE OF THE ARCH DOESN'T APPEAR TO BE EXTREME, IT SEEMS TO HAVE BEEN EXACERBATED BY THE FORMATION OF THE ANEURYSM. THE SKETCH SHOWS AN ALMOST GOTHIC FORMATION OF THE AORTIC WALL BETWEEN THE ANEURYSM AND THE DESCENDING AORTA, AND THIS CORRESPONDS WITH THE LOCATION OF THE STENOSIS IN THE POST-OP IMAGES. AS THE FULL BATCH REVIEW CONFIRMED THE DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ISSUES FOUND AND THE IMAGING SHOWS RELATIVELY HIGH ANGULATION THE STENOSIS WAS AT LEAST IN PART CAUSED BY THE PATIENT'S ANATOMY. NO CAUSAL LINK BETWEEN THE EVENT AND THE DEVICE COULD BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: CLINICAL CODE: 2263 -STENOSIS - STENOSIS REPORTED IN THE STENTED SECTION OF THE THORAFLEX HYBRID DEVICE . 1942 - ISCHEMIA - INTESTINAL ISCHEMIA REPORTED ONSET DATE (B)(6) 2025. SYMPTOMS OF INTESTINAL ISCHEMIA WERE CONFIRMED, AND AN EMERGENCY CT SCAN WAS PERFORMED. STENOSIS IN THE STENT GRAFT SECTION WAS CONFIRMED. THIS CAUSED CARDIAC STRESS, LEADING TO CARDIAC DYSFUNCTION. IMPACT CODE: 4624 - SURGICAL INTERVENTION -EMERGENCY STENT GRAFTING WAS PERFORMED. BLOOD PRESSURE WAS MEASURED AT 97/45 IN THE UPPER LIMBS AND AT 72/45 IN THE LOWER LIMBS, INDICATING A PRESSURE DIFFERENCE. IT WAS DIFFICULT TO ADVANCE A PIGTAIL CATHETER ALONE THROUGH THE THORAFLEX HYBRID, SO THE PIGTAIL CATHETER WAS REPLACED WITH A LUNDERQUIST (COOK MEDICAL). THEN A VALIENT (B)(6), MEDTRONIC) WAS INSERTED AND IMPLANTED TO COVER THE STENT GRAFT SECTION OF THE THORAFLEX HYBRID. AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. THE STENOSIS WAS SLIGHTLY IMPROVED. THE PRESSURE DIFFERENCE WAS ALMOST RESOLVED, AND CARDIAC FUNCTION RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED. DEVICE PROBLEM CODE : 4066 -DEVICE STENOSIS - STENOSIS REPORTED IN THE STENTED SECTION OF THE THORAFLEX HYBRID DEVICE . AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: -THORAFLEX HYBRID SALES JAN 21 - JUL 25 VS THORAFLEX HYBRID STENOSIS EVENTS (B)(6) 2025 HAD AN OCCURRENCE RATE OF (B)(4) NO TREND REQUIRING ACTION HAS BEEN IDENTIFIED. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION HAS BEEN REQUESTED TO AID THIS INVESTIGATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW WAS PERFORMED FROM BASE FABRIC TO FINISHED PRODUCT FOR DEVICE ID- 25952361 WHICH CONFIRMED THE DEICE WAS MANUFACTURED TO SPECIFICATION WITH NO ISSUES FOUND. 4117 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION CONCLUSION: 11 - CONCLUSION NOT YET AVAILABLE AS INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    STENOSIS IN THE STENT GRAFT SECTION OF THORAFLEX HYBRID DEVICE. ON (B)(6) 2025, A BENTALL PROCEDURE WITH TAR-FET WAS PERFORMED. A GELWEAVE VALSALVA (WE-40281ADP) AND AN INSPIRIS (23MM, EDWARDS LIFESCIENCES) WERE USED TO CREATE A COMPOSITE GRAFT AND A BENTALL PROCEDURE WAS PERFORMED. THE ZONE 1 AORTA WAS CUT, AND THE THORAFLEX HYBRID WAS INSERTED. THE THORAFLEX HYBRID WAS DEPLOYED AS PER THE IFU, (INSTRUCTIONS FOR USE) AND THE PERIPHERAL PART OF THE DEVICE WAS ANASTOMOSED. THE CENTRAL PORTION OF THE GRAFT PORTION OF THE DEVICE WAS ANASTOMOSED WITH THE COMPOSITE GRAFT. THE THIRD BRANCH (LEFT SUBCLAVIAN ARTERY) OF THE THORAFLEX HYBRID WAS FIRST BYPASSED TO THE LEFT AXILLARY ARTERY USING A VASCULAR GRAFT TO CIRCULATE BLOOD. THE SECOND BRANCH OF THE THORAFLEX HYBRID WAS THEN ANASTOMOSED TO THE LEFT COMMON CAROTID ARTERY (LCCA). THE FIRST BRANCH OF THE THORAFLEX HYBRID WAS FINALLY ANASTOMOSED TO THE BRACHIOCEPHALIC TRUNK (BCT) TO COMPLETE ANASTOMOSIS OF THE NECK BRANCHES. ON (B)(6) SYMPTOMS OF INTESTINAL ISCHEMIA WERE CONFIRMED, AND AN EMERGENCY CT SCAN WAS PERFORMED. STENOSIS IN THE STENT GRAFT SECTION WAS CONFIRMED. THIS CAUSED CARDIAC STRESS, LEADING TO CARDIAC DYSFUNCTION. ON (B)(6), EMERGENCY STENT GRAFTING WAS PERFORMED. BLOOD PRESSURE WAS MEASURED AT 97/45 IN THE UPPER LIMBS AND AT 72/45 IN THE LOWER LIMBS, INDICATING A PRESSURE DIFFERENCE. IT WAS DIFFICULT TO ADVANCE A PIGTAIL CATHETER ALONE THROUGH THE THORAFLEX HYBRID, SO THE PIGTAIL CATHETER WAS REPLACED WITH A LUNDERQUIST (COOK MEDICAL). THEN A VALIENT (VAMF3636150TJ, MEDTRONIC) WAS INSERTED AND IMPLANTED TO COVER THE STENT GRAFT SECTION OF THE THORAFLEX HYBRID. AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. THE STENOSIS WAS SLIGHTLY IMPROVED. THE PRESSURE DIFFERENCE WAS ALMOST RESOLVED, AND CARDIAC FUNCTION RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECIEVED ON 25 SEP 25 STATING THE PATIENT PASSED AWAY. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00072 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).

    Description of Event or Problem · 0

    STENOSIS IN THE STENT GRAFT SECTION OF THORAFLEX HYBRID DEVICE. ON (B)(6) 2025, A BENTALL PROCEDURE WITH TAR-FET WAS PERFORMED. A GELWEAVE VALSALVA (WE-40281ADP) AND AN INSPIRIS (23MM, EDWARDS LIFESCIENCES) WERE USED TO CREATE A COMPOSITE GRAFT AND A BENTALL PROCEDURE WAS PERFORMED. THE ZONE 1 AORTA WAS CUT, AND THE THORAFLEX HYBRID WAS INSERTED. THE THORAFLEX HYBRID WAS DEPLOYED AS PER THE IFU,( INSTRUCTIONS FOR USE) AND THE PERIPHERAL PART OF THE DEVICE WAS ANASTOMOSED. THE CENTRAL PORTION OF STENT GRAFT PORTION OF THE DEVICE WAS ANASTOMOSED WITH THE COMPOSITE GRAFT. THE THIRD BRANCH (LEFT SUBCLAVIAN ARTERY) OF THE THORAFLEX HYBRID WAS FIRST BYPASSED TO THE LEFT AXILLARY ARTERY USING A VASCULAR GRAFT TO CIRCULATE BLOOD. THE SECOND BRANCH OF THE THORAFLEX HYBRID WAS THEN ANASTOMOSED TO THE LEFT COMMON CAROTID ARTERY (LCCA). THE FIRST BRANCH OF THE THORAFLEX HYBRID WAS FINALLY ANASTOMOSED TO THE BRACHIOCEPHALIC TRUNK (BCT) TO COMPLETE ANASTOMOSIS OF THE NECK BRANCHES. ON (B)(6), SYMPTOMS OF INTESTINAL ISCHEMIA WERE CONFIRMED, AND AN EMERGENCY CT SCAN WAS PERFORMED. STENOSIS IN THE STENT GRAFT SECTION WAS CONFIRMED. THIS CAUSED CARDIAC STRESS, LEADING TO CARDIAC DYSFUNCTION. ON (B)(6), EMERGENCY STENT GRAFTING WAS PERFORMED. BLOOD PRESSURE WAS MEASURED AT 97/45 IN THE UPPER LIMBS AND AT 72/45 IN THE LOWER LIMBS, INDICATING A PRESSURE DIFFERENCE. IT WAS DIFFICULT TO ADVANCE A PIGTAIL CATHETER ALONE THROUGH THE THORAFLEX HYBRID, SO THE PIGTAIL CATHETER WAS REPLACED WITH A LUNDERQUIST (COOK MEDICAL). THEN A VALIENT (B)(6), MEDTRONIC) WAS INSERTED AND IMPLANTED TO COVER THE STENT GRAFT SECTION OF THE THORAFLEX HYBRID. AS THE STENOTIC PORTION WAS NOT FULLY EXPANDED, A RELIANT STENT GRAFT BALLOON CATHETER (MEDTRONIC) WAS USED TO EXPAND IT FROM THE INSIDE. THE STENOSIS WAS SLIGHTLY IMPROVED. THE PRESSURE DIFFERENCE WAS ALMOST RESOLVED, AND CARDIAC FUNCTION RETURNED TO NORMAL. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2886514 THORAFLEX HYBRID THORAFLEX HYBRID PLEXUS QSK VASCUTEK LTD. N/A 25952361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| D