Thoraflex HybridRecalls & reported problems across all models
Vascutek Ltd · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 78
- Deaths reported
- 16
- Injuries reported
- 55
- Recalls
- 0
We found 33 models of Thoraflex Hybrid by Vascutek Ltd in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2022 and Sep 29, 2026 — classified as 16 deaths, 55 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (48 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Thoraflex Hybrid problems
Device problems
- Insufficient Device Problem Information48
- Adverse Event Without Identified Device or Use Problem34
- Deformation Due to Compressive Stress3
- Device Endoleak3
- Obstruction of Flow3
- Fluid/Blood Leak2
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Thrombosis/Thrombus22
- Insufficient Information9
- Stroke/CVA9
- Hemorrhage/Blood Loss/Bleeding7
- No Clinical Signs, Symptoms or Conditions6
- Aortic dissection5
- Clinical Endoleak4
- Obstruction/Occlusion4
Thoraflex Hybrid models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Thoraflex™ Hybrid THP3032X100AHybrid stent graft, thoracic aortic lesion treatment3 deaths8 reports
- Thoraflex™ Hybrid THP3036X100AHybrid stent graft, thoracic aortic lesion treatment7 reports
- Thoraflex™ Hybrid THP2830X100AHybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THP3032X150AHybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THA3036X150AHybrid stent graft, thoracic aortic lesion treatment4 reports
- Thoraflex™ Hybrid THP3036X150AHybrid stent graft, thoracic aortic lesion treatment1 death3 reports
- Thoraflex™ Hybrid THA2830X100AHybrid stent graft, thoracic aortic lesion treatment1 death3 reports
- Thoraflex™ Hybrid THA3032X150AHybrid stent graft, thoracic aortic lesion treatment2 deaths3 reports
- Thoraflex™ Hybrid THA3034X150AHybrid stent graft, thoracic aortic lesion treatment3 reports
- Thoraflex™ Hybrid THP2224X100BHybrid stent graft, thoracic aortic lesion treatment3 reports
- Thoraflex™ Hybrid THP2628X100AHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP3038X100AHybrid stent graft, thoracic aortic lesion treatment1 death2 reports
- Thoraflex™ Hybrid THP2628X150AHybrid stent graft, thoracic aortic lesion treatment1 death2 reports
- Thoraflex™ Hybrid THP3034X150AHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP3038X150AHybrid stent graft, thoracic aortic lesion treatment1 death2 reports
- Thoraflex™ Hybrid THA3034X100AHybrid stent graft, thoracic aortic lesion treatment1 death2 reports
- Thoraflex™ Hybrid THA2628X150AHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THA3038X150AHybrid stent graft, thoracic aortic lesion treatment2 deaths2 reports
- Thoraflex™ Hybrid THA3240X150AHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP2628X100BHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP2830X100BHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP3032X100BHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP2224X100EHybrid stent graft, thoracic aortic lesion treatment2 reports
- Thoraflex™ Hybrid THP2426X100AHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THA2830X150AHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THP3038X100BHybrid stent graft, thoracic aortic lesion treatment1 death1 report
- Thoraflex™ Hybrid THP3040X100BHybrid stent graft, thoracic aortic lesion treatment1 death1 report
- Thoraflex™ Hybrid THP2830X150BHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THP3032X150BHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THP3036X150BHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THA3038X100BHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THP2426X100EHybrid stent graft, thoracic aortic lesion treatment1 report
- Thoraflex™ Hybrid THP3034X100EHybrid stent graft, thoracic aortic lesion treatment1 death1 report
Recent Thoraflex Hybrid adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
Patient problems: Thrombosis/Thrombus
MAUDE report 50927783 ↗InjurySep 25, 2026Insufficient Device Problem Information
Event reported from clinical study Extend - NCT05639400.Type 1C Endoleak, was noted intraoperatively from right renal bridging stent on (b)(6) 2026 for patient (b)(6).Treatment of the event included a VBX stent placement on (b)(6) 2026. The event was considered resolved with treatment and sequalae on (b)(6) 2026. The patient continued in the study.The investigator considered the event of Type 1C Endoleak as serious with moderate severity and related to the device.The site provided an update on 28 Aug 26 stating that this event is related to the Thoraflex Hybrid procedure and related to the Thoraflex Hybrid device.
Patient problems: Clinical Endoleak
MAUDE report 50895652 ↗InjurySep 9, 2026Insufficient Device Problem Information
Event reported as Thrombus Distal thrombus inside the stent at the junction of the graft. One day following the initial procedure, the patient was placed on aspirin and had a CT(Computed Tomography) scan with the vascular surgeons as part of a follow-up for TEVAR(Thoracic Endovascular Aortic Repair). Thombus identified on transoesophageal echocardiography (TOE). The treating vascular surgeon reported that the thoracic stent graft was appropriately deployed and fully expanded. 6hr bypass time, blood transfusion given but no excessive products given. No death/serious injury. No surgical intervention. Sales associate has requested patient condition follow up report.
Patient problems: Thrombosis/Thrombus
MAUDE report 50685343 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.
Patient problems: Thrombosis/Thrombus
MAUDE report 25887482 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.
Patient problems: Thrombosis/Thrombus
MAUDE report 25887480 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS
Patient problems: Thrombosis/Thrombus
MAUDE report 25887462 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.
Patient problems: Thrombosis/Thrombus
MAUDE report 25887446 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.
Patient problems: Thrombosis/Thrombus
MAUDE report 25887429 ↗InjuryJul 21, 2026Insufficient Device Problem Information
EVENTS REPORTED FROM INSEL GRUPPE AG - 3064, VIA SWISSMEDIC REPORT. EVENTS REPORTED AS THROMBUS AFTER FROZEN ELEPHANT TRUNK. THROMBUS AT THE DISTAL STENT END OF THE FROZEN ELEPHANT TRUNK IS A WELL-KNOWN COMPLICATION. IN THE LITERATURE, THE INCIDENCE IS GIVEN AS ABOUT 8-16%. RECENTLY, WE HAVE HAD THE IMPRESSION THAT THIS COMPLICATION IS OCCURRING MORE OFTEN IN OUR COUNTRY. THE SITE COMPILED THE CASES OF THE LAST THREE MONTHS, IT WAS FOUND THAT 5 OUT OF 12 PATIENTS HAD A DISTAL THROMBUS, WHICH IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. THIS IS SIGNIFICANTLY HIGHER THAN THE RATE DESCRIBED IN THE LITERATURE. IN ADDITION, THERE WAS A CASE WITH SERIOUS CLINICAL CONSEQUENCES LAST NOVEMBER. DESPITE CAREFUL INTRA-OPERATIVE MEASURES AND ESTABLISHED AVOIDANCE STRATEGIES ON OUR PART, THROMBI FORMATION CONTINUES TO OCCUR, WHICH IS WHY WE WOULD LIKE TO REPORT THIS.
Patient problems: Thrombosis/Thrombus
MAUDE report 25887392 ↗InjuryJul 16, 2026Adverse Event Without Identified Device or Use Problem
EVENT REPORTED BY THOR - (B)(4). PATIENT (B)(6), A WHITE MALE WITH AORTIC CHRONIC DISSECTION, EXPERIENCED AN EVENT OF DSINE (DISTAL STENT GRAFT INDUCED NEW ENTRY). THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 2021. ON POST OPERATIVE DAY 369 ((B)(6)2022), PATIENT (B)(6) HAD AN AE (ADVERSE EVENT) OF DSINE (ON CT SCAN FROM (B)(6) 2022 WAS A DSINE DETECTABLE). TREATMENT OF THIS AE INCLUDED REINTERVENTION, TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 2022. THE AE WAS CONSIDERED RESOLVED ON (B)(6) 2022 AND THE PATIENT CONTINUED IN THE STUDY.
Patient problems: Aortic dissection
MAUDE report 25835011 ↗InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
EVENT REPORTED BY THOR - (B)(4). PATIENT 027, A WHITE FEMALE WITH AORTIC CHRONIC DISSECTION, EXPERIENCED AN EVENT OF DSINE( DISTAL STENT GRAFT INDUCED NEW ENTRY). THE PATIENT UNDERWENT AN OPEN SURGICAL REPLACEMENT OF THE AORTA WITH A THORAFLEX HYBRID PLEXUS DEVICE ON (B)(6) 21. ON POST OPERATIVE DAY 384 ((B)(6) 22), PATIENT 027 HAD AN AE(ADVERSE EVENT) OF DSINE (ON CT SCAN FROM (B)(6).2022 WAS A DSINE DETECTABLE). TREATMENT OF THIS AE INCLUDED REINTERVENTION, TEVAR(THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 23. THE EVENT WAS CONSIDERED RESOLVED ON 11-MAY-23 AND THE PATIENT CONTINUED IN THE STUDY.
Patient problems: Aortic dissection
MAUDE report 25824770 ↗InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED FROM THE THOR STUDY (NCT03414866). ON POST OPERATIVE DAY 1 (ON (B)(6) 2021), PATIENT 029 HAD AN ADVERSE EVENT OF DSINE (DISTAL STENT GRAFT INDUCED NEW ENTRY) (ON CT SCAN FROM ON (B)(6) 2021 WAS A DSINE DETECTABLE). TREATMENT OF THIS ADVERSE EVENT INCLUDED REINTERVENTION, TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) -IMPLANTATION ON (B)(6) 2021. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2021 AND THE PATIENT CONTINUED IN THE STUDY. CONCOMITANT MEDICATIONS INCLUDED: ENOXAPARIN (CLEXANE S.C.), ACETYLSALICYLIC ACID (ASS). THE INVESTIGATOR CONSIDERED THE EVENT OF DSINE AS MODERATE SEVERITY AND RELATED TO THE THORAFLEX HYBRID PLEXUS DEVICE.
Patient problems: Aortic dissection
MAUDE report 25823704 ↗DeathJun 18, 2026Adverse Event Without Identified Device or Use Problem
PATIENT EXPIRED IN THE OPERATING ROOM AFTER A SUCCESSFUL THORAFLEX HYBRID DEPLOYMENT. SEVERE BLEEDING AT THE POSTERIOR COLLAR ANASTOMOSIS SITE DUE TO POOR TISSUE QUALITY (DISSECTION/ANEURYSMAL) AND CHALLENGING LOCATION TO REPAIR WITH SUTURE. OUTER STRIP OF FELT USED FOR INITIAL COLLAR ANASTOMOSIS FOLLOWED BY NUMEROUS PLEDGETS AFTER DISTAL RE-PERFUSION. THE CHEST INCISION WAS EXTENDED LATERALLY FOR BETTER AORTIC EXPOSURE. THE PATIENT DEVELOPED A SEVERE COAGULOPATHY AND MULTIPLE BLOOD TRANSFUSIONS. THE GORE REP WAS CALLED EMERGENTLY FOR DISTAL EXTENSIONS, AND TERUMO WAS INFORMED THE FOLLOWING MORNING THAT THE PATIENT EXPIRED ON THE OPERATING ROOM TABLE. ELOPED A SEVERE COAGULOPATHY AND MULTIPLE BLOOD TRANSFUSIONS. THE GORE REP WAS CALLED EMERGENTLY FOR DISTAL EXTENSIONS, AND TERUMO WAS INFORMED THE FOLLOWING MORNING THAT THE PATIENT EXPIRED ON THE OPERATING ROOM TABLE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25543717 ↗DeathApr 7, 2026Microbial Contamination of Device
EVENT OF INFECTION REPORTED FROM (B)(6). DEATH OF THE PATIENT IN RESUSCITATION. PATIENT OPERATED ON (B)(6) 2025 FOR A REPLACEMENT OF THE AORTIC ARCH WITH REIMPLANTATION OF THE SUPRA-AORTIC TRUNKS AND PLACEMENT OF A DESCENDING THORACIC AORTIC PROSTHESIS (THORAFLEX), ON AN ANEURYSM OF THE AORTIC ARCH. NEW HOSPITALIZATION ON 25/10 FOR FEVER AND PERIPROSTHETIC COLLECTION. SURGICAL DRAINAGE OF A PURULENT PERICARDIAL COLLECTION THAT CAME BACK POSITIVE FOR CUTI BACTERIUM ACNES WITH IRRIGATION, WASHING, THEN ACTIVE DRAINAGE UNTIL 17/11 ONCE THE BACTERIOLOGICAL SAMPLES ARE NEGATIVE. ON (B)(6) 2025: PET-CT PERFORMED OBJECTIFYING THE PRESENCE OF A THORACIC HYPERMETABOLIC INFILTRATION COMING INTO CONTACT WITH THE ASCENDING THORACIC AORTIC PROSTHESIS, THE SITE OF HETEROGENEOUS FIXATION: SUSPICION OF A PROGRESSIVE INFECTIOUS PROCESS. HOSPITALIZATION IN CARDIAC SURGERY FOR NEW SURGICAL TRIMMING AND DRAINAGE BY STERNAL VAC (UNDERSTOOD TO BE VACUM ASSISTED CLOSURE SYSTEM) AND INFECTIOUS FOLLOW-UP SCINTIGRAPHY WITH LABELED LEUKOCYTES (B)(6) 2026, REVEALING AN INFECTION OF THE AORTIC PROSTHESIS, WITHOUT ANY OTHER HYPER FIXATION FOCUS. ON (B)(6) 2026: COMPLETE SURGICAL REVISION FOR REMOVAL - REINSTALL
Patient problems: Bacterial Infection
MAUDE report 24797689 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EVENT OF WORSENING TYPE 1B ENDOLEAK REPORTED FORM EXTEND STUDY (B)(4). ON POST OPERATIVE DAY 722(INDEX PROCEDURE)/284(EXTENSION PROCEDURE), THE SUBJECT HAD A (COMPUTERISED TOMOGRAPHY) CT SCAN ON (B)(6) 2026 WHICH SHOWED MULTIPLE STABLE UNCLASSIFIED ENDOLEAKS IN THE PROXIMAL STENT AND MIDPORTION OF THE STENT WITH OVERALL STABLE AGGREGATE DIAMETER MEASURING UP TO 7.2CM. ON (B)(6) 2025, CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) REVEALED INTERVAL GROWTH OF THE PROXIMAL DESCENDING AORTA MEASURING A MAXIMUM OF 7.1 CM IN DIAMETER. FOLLOW-UP IMAGING IN (B)(6) 2025 SHOWED ONGOING LEAK FROM THE DISTAL GRAFT. TREATMENT OF THE EVENT ON (B)(6)2026 INCLUDED EXTENSION THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) VIA RIGHT CFA (UNDERSTOOD TO BE COMMON FEMORAL ARTERY) CUTDOWN. THE VASCULAR PROCEDURE INCLUDED PERCUTANEOUS ACCESS OF THE RIGHT FEMORAL ARTERY WITH A 7-FRENCH SHEATH, A RIGHT ILIAC ANGIOGRAM, AND A STENTING OF THE RIGHT COMMON ILIAC ARTERY AND EXTERNAL ILIAC. TYPE 1B ENDOLEAK OF A THORACIC ENDOVASCULAR AORTIC REPAIR GRAFT DONE PREVIOUSLY AFTER THE PATIENT HAS AN EXTENSIVE HISTORY OF TYPE A AORTIC DISSECTION AND EXTENSIVE RECONSTRUCTION. THIS INTERVENTION WAS NOT REQUIRED AS A RESULT OF A DEVI
Patient problems: Clinical Endoleak
MAUDE report 24452309 ↗
Other Vascutek Ltd products
All Vascutek Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page