VALIANT® Captivia VAMF3636C200TU (UDI 00643169346567)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169346567), received between Mar 21, 2017 and Dec 2, 2025 — classified as 7 deaths, 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (13 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• DeathDec 2, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS SYMPTOMATIC FOR MULTIPLE PENETRATING AORTIC ULCERS AND WAS IMPLANTED WITH MULTIPLE ENDOGRAFTS, INCLUDING THREE VALIANT CAPTIVIA STENT GRAFTS ( VAMF3636C200TU , TWO VAMF3636C150TU) AND AN ENDURANT AUI STENT GRAFT SYSTEM (ETUF3614C102E, ETLW1613C146E). THE PHYSICIAN CONCLUDED THE PROCEDURE WITH A FEM-FEM BYPASS WHICH WAS NOT PLANNED PRE-OPERATIVELY. IT WAS SAID THAT THE FEM-FEM BYPASS WAS PERFORMED BECAUSE THERE WAS EXCESSIVE OVER SIZING WITH THE VAMF3636C200TU STENT GRAFT DIAMETER. THE STENT GRAFT INFOLDED AND RIGHT ILIAC VESSEL OCCLUSION OCCURRED. THE OCCLUSION WAS DESCRIBED AS NOT THROMBUS-RELATED. THE PATIENT DIED POST OPERATIVELY, BUT THE CAUSE OF DEATH AND DATE OF DEATH ARE UNKNOWN. THE PATIENT'S CONDITION IN THE IMMEDIATE POST-OPERATIVE IS UNKNOWN. THE PATIENT DEATH WAS ASSESSED BY THE PHYSICIAN AS RELATED TO THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23690803 ↗
• DeathNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 200MM THORACIC AORTIC DISSECTION. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH A TYPE B DISSECTION 2 MONTHS PRIOR TO THE INDEX PROCEDURE. DURING A PRIOR HOSPITALIZATION, THE PATIENT DEVELOPED A BOWEL OBSTRUCTION REQUIRING SURGICAL INTERVENTION. FOLLOWING RECOVERY, THE PATIENT UNDERWENT TEVAR. THE INDEX PROCEDURE WENT WELL, AND THE TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED WITH NO ISSUES AND THE PATENT WAS DISCHARGED. 8 DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED EXTREME PAIN THAT DISRUPTED SLEEP. SUBSEQUENT CT IMAGING REVEALED AN ASCENDING HEMATOMA. EMERGENCY INTERVENTION TO REPAIR THE ASCENDING AORTIC ARCH WAS PERFORMED THE FOLLOWING THE MORNING.THE ASCENDING ARCH WAS REPAIRED HOWEVER, THE PATIENT SUFFERED CARDIAC ARREST UPON WAKING AND COULD NOT BE RESUSCITATED, RESULTING IN DEATH 9 DAYS POST INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE ASCENDING HEMATOMA IS UNDETERMINED.

  Patient problems: Cardiac Arrest; Hematoma; Pain

  MAUDE report 20734560 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  4 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR TREATMENT OVER 1 MONTH 2 AT EACH PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURES A VALIANT NAVION STENT GRAFT (VNMC4040C95TU) WAS IMPLANTED DURING THE RE-INTERVENTION OF A THORACIC AORTIC REPAIR. APPROXIMATELY 5 MONTHS POST THE NAVION IMPLANT FOLLOW UP CT SHOWED THE MAX AORTIC DIAMETER WAS NOTED AS 72.9MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. THE CAUSE OF THE REINTERVENTION IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 18941769 ↗
• MalfunctionOct 27, 2023Material Deformation; Material Deformation

  A VALIANT CAPTIVIA STENT GRAFT (VAMF3636C200TU) WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN 70MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE VALIANT CAPTIVIA DELIVERY SYSTEM KINKED WHILE TRYING TO ADVANCE INTO THE ARCH OF THE AORTA. THE DELIVERY SYSTEM AND GRAFT WERE WITHDRAWN AND A SHORTER REPLACEMENT GRAFT WAS IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE KINK IN THE DEVICE¿S DELIVERY SYSTEM WAS ANATOMY-RELATED DUE TO STEEP ARCH IN THE PATIENT¿S AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019696 ↗
• InjuryJul 28, 2023Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN TAA . IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN SHOWED A LARGE TYPE IA AND IB ENDOLEAK. INTERVENTION WAS PERFORMED THE FOLLOWING DAY AND THE PROXIMAL SEAL WAS EXTENDED WITH A NON MDT GRAFT AND THE DISTAL SEAL WAS EXTENDED WITH A MEDTRONIC GRAFT AND REINFORCED WITH ENDOANCHORS. THE ENDOLEAKS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS WAS PATIENT ANATOMY. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17412463 ↗
• DeathMar 10, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  2 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 61MM DESCENDING THORACIC AORTIC ANEURYSM ON (B)(6) 2016. THE STENT GRAFT MODEL VAMF3636C200TU WAS IMPLANTED PROXIMALLY AND VAMC3838C150TU DISTALLY. IT WAS NOTED THAT THERE WAS AT LEAST 50MM OF OVERLAP BETWEEN THE STENT GRAFTS. THE PATIENT HAD AN ASCENDING AORTIC ANEURYSM TREATED WITH ASCENDING AND HEMIARCH REPLACEMENT PERFORMED APPROXIMATELY 4 MONTHS PREVIOUSLY. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE WITH COMPLAINTS OF SHORTNESS OF BREATH AND ABDOMINAL DISTENTION. A CT SCAN WAS PERFORMED AND REVEALED RIGHT PLEURAL EFFUSION. THE PATIENT WAS THEN TRANSFERRED TO A DIFFERENT HEALTHCARE FACILITY. OVER THE COURSE OF THE ADMISSION, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND DISTENTION. THE PATIENT WAS DISCHARGED 3 DAYS LATER. THE FOLLOWING DAY THE PATIENT COMPLAINED OF SEVERE ABDOMINAL PAIN, PARTICULAR IN THE UPPER ABDOMEN, WHICH WORSENED WITH MOVEMENT. A CT SCAN IDENTIFIED THE PRESENCE OF "DIFFUSE AIR BUBBLES WITHIN THE ABDOMEN. THERE APPEARED TO BE PNEUMATOSIS WITHIN THE WALL OF THE STOMACH. THERE IS FREE FLUID WITHIN THE

  Patient problems: Dyspnea; Insufficient Information; Necrosis; Obstruction/Occlusion; Pain; Pleural Effusion

  MAUDE report 16520043 ↗
• DeathJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOUR VALIANT CAPTIVIA STENT GRAFTS AND AN ENDURANT II BIFURCATE STENT GRAFT SYSTEM WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A >90MM TAAA. IT WAS REPORTED THAT 2 DAYS LATER THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN BUT THE PHYSICIAN STATED IT WAS POSSIBLY THE ASCENDING THORACIC OR A CARDIAC ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16240551 ↗
• DeathJan 24, 2023Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE AN UNDETERMINED ENDOLEAK WAS OBSERVED. INTERVENTION WAS COMPLETED WHERE A VALIANT NAVION STENT GRAFT WAS IMPLANTED. FOLLOW UP CTS 4 DAYS POST THE INTERVENTION, AND AT 1 AND 2 MONTHS POST THE INTERVENTION ALL NOTED THE UNDETERMINED ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND DEATH IS UNDETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 16233570 ↗
• InjuryDec 9, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED APPROXIMATLEY 1 YEAR LATER. IT WAS CONFIRMED THAT THE MOST PROXIMAL STENT GRAFT WAS THE VALIANT NAVION VNMF4646C103TU IMPLANTED AS AN EXTENSION PLACED INSIDE THE VALIANT CAPTIVIA VAMF4036C150TU. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEURE THE PATENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH UNKNOWN SYMPTOMS , WHERE A CT WAS PERFORMED AND REVEALED AN ENDOLEAK  IN THE PROXIMAL DESCENDING AORTA WHERE 4 ENDOGRAFTS WERE PREVIOUSLY PLACED. THE PATIENT WAS BROUGHT TO OR WHERE A ANGIOGRAM IN OR REVEALED A TYPE III ENDOLEAKCOMING FROM 2 OF THE MOST PROXIMAL STENT GRAFTS , A VALIANT NAVION VNMF4646C103TU & A VALIANT CAPTIVA VAMF4036C150TU. THE PHYSICIAN STATED AT THE TIME IT WAS EITHER A DISJUNCTION AND/OR STENT FRACTURE. THE EVENT WAS TREATED ON THE SAME DAY WITH 3 VALIANT CAPTIVIA IMPLANTED TO RELINE THE THORACIC AORTA. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE CORELAB REVIEW OF IMAGES FROM (B)(6) 202

  Patient problems: Insufficient Information

  MAUDE report 15948353 ↗
• InjuryNov 15, 2022Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR AORTIC REPAIR APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE. THE NAVION GRAFT WAS IMPLANTED DISTALLY TO THE EXISTING GRAFTS. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IA ENDOLEAK. CORE LAB REVIEW OF CT IMAGING FROM 09-SEP-2022 FOR THE NAVION STENT GRAFT IDENTIFIED NEW STENT RING ENLARGEMENT OF +1.4MM. NO ENDOLEAK, STENT FRACTURE, STENT RING MIGRATION OR AORTIC ENLARGEMENT WERE IDENTIFIED. A TYPE IA ENDOLEAK WAS OBSERVED ON A NON NAVION DEVICE. IT WAS NOTED THE NON NAVION DEVICE WAS NOT A BIFURCATED DEVICE. A PLANNED INTERVENTION ONE MONTH POST IMAGING (TEVAR REPAIR FOR THE TYPE IA ENDOLEAK WITH LASER FENESTRATION AND LSA STENTING) WAS ABORTED DUE TO RESISTANCE OF STENT GRAFT THROUGH THE ILIAC VESSELS BILATERALLY. A LEFT AND RIGHT OCCLUSION OCCURRED LEADING TO EMERGENT EXPLORATORY EMBOLECTOMY, PATCH ANGIOPLASTY AND ENDARTERECTOMY. THE CAUSE OF THE TYPE IA ENDOLEAK AND STENT RING ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATI

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 15795949 ↗
• DeathMay 30, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT NAVION GRAFT WAS IMPLANTED 3 MONTHS LATER DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT CAPTIVIA WAS IMPLANTED 16 MONTHS LATER. THREE VALIANT NAVIONS WERE IMPLANTED AS PART OF A REINTERVENTION FOR PRIOR AORTIC REPAIR APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT WAS COMPLETED AFTER THE PATIENT BECAME UNWELL. A TYPE II ENDOLEAK AND MULTIPLE UNKNOWN ENDOLEAKS WERE OBSERVED. NEW ANEURYSMAL DEGENERATION OF THE TEVAR AT THE PROXIMAL PART WAS NOTED WHICH RESULTED IN AN ENDOLEAK REQUIRING PROXIMAL EXTENSION. DIFFERENTIAL DIAGNOSIS INCLUDED AORTIC RUPTURE VS. EMBOLIC INFARCT TO THE SPLEEN. IT WAS REPORTED THE PATIENT EXPIRED THE DAY AFTER THE CT. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO MULTIPLE CAUSES - INFARCTION, INFECTION AND AORTIC RUPTURE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Embolism/Embolus; Insufficient Information; Rupture; Unspecified Infection

  MAUDE report 14539942 ↗
• InjuryMay 5, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION OF AN UNKNOWN LENGTH .  IT WAS REPORTED THAT , THE PATIENT HAD AN INCIDENTAL FINDING OF A TYPE IB ENDOLEAK . THE PHYSICIAN ADDED A DISTAL EXTENSION AND THE TYPE IB ENDOLEAK WAS RESOLVED ON THE SAME DATE. AS PER THE PHYSICIAN THE CAUSE OF THE TYPE IB ENDOLEAK WAS AS A RESULT OF AN INADEQUATE DISTAL SEAL ZONE.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14285337 ↗
• InjuryFeb 28, 2020Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP 3 YEARS AND 3 MONTHS LATER, A CT WAS PERFORMED WHERE CONTRAST IN THE SAC WAS PRESENT. INITIALLY IT WAS UNCLEAR WHETHER IT WAS A TYPE II OR TYPE III ENDOLEAK. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED ON THE SAME DATE AND THE ENDOLEAK WAS CONFIRMED TO BE A TYPE IIIB GRAFT DEFECT. AS PER THE PHYSICIAN IT WAS BELIEVED THAT THE BARE STENT OF THE 32MM DISTAL COMPONENT HAS ERODED THROUGH THE FABRIC OF THE 36MM PROXIMAL COMPONENT. THERE WAS NO CHANGE IN ANEURYSM SAC DIAMETER SINCE INITIAL IMPLANT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS FRICTION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9768567 ↗
• DeathOct 8, 2018Difficult to Remove; Difficult to Remove

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENTS ILIAC ARTERIES WERE VERY CALCIFIED IT WAS REPORTED DURING THE INDEX PROCEDURE THAT SOME RESISTANCE OCCURRED WHILE DELIVERING THE PROXIMAL STENT GRAFT TO THE TARGET LOCATION, HOWEVER, THE DEVICE WAS ABLE TO PASS TO THE THORACIC PROXIMAL LANDING ZONE WITHOUT HAVING TO REMOVE THE DELIVERY SYSTEM OR PERFORM ANY ADJUNCTIVE PROCEDURES SUCH AS BALLOONING OR STENTING. ONCE THE STENT GRAFT WAS DEPLOYED THE DELIVERY SYSTEM WAS RE-CAPTURED USING THE CORRECT TECHNIQUE, HOWEVER, IT WAS REPORTED WHEN THE PHYSICIAN PULLED THE DEVICE BACK THROUGH THE ILIAC, THE DEVICE WOULD NOT PASS. THE DEVICE WAS PULLED WITH SLIGHTLY MORE FORCE AND WAS SUCCESSFULLY REMOVED THROUGH THE FEMORAL ACCESS POINT. A RUPTURE WAS CALLED AT THE TIME OF THE DELIVERY SYSTEM REMOVAL. THE PHYSICIAN THEN PLACED AN OCCLUSION BALLOON IN THE PROXIMAL LEFT COMMON ILIAC THROUGH A LARGE 18FR SHEATH AND PUSHED CONTRAST RETROGRADE THROUGH THE SHEATH TO SEE EXTRAVASATION FROM THE EXTERNAL ILIAC ARTERY. A COVERED STENT WAS PLACED TO GAIN HEMOSTATIC CONTROL OF THE ILIAC ARTERY,

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 7943154 ↗
• MalfunctionJul 2, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP PERFORMED APPROXIMATELY 1.5 YEAR POST INDEX PROCEDURE, A TYPE IB ENDO LEAK WAS DETECTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION AND DISTAL AORTA DILATED BEYOND SIZE OF THE ENDOGRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7654401 ↗
• MalfunctionJun 6, 2018Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED FOR IMPLANTATION IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 75MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE SURGEON TRIED TO ADVANCE THE DEVICE UP THE PATIENTS LEFT SIDE BUT THE DEVICE WOULD NOT ADVANCE. THE RIGHT SIDE WAS DILATED TO ATTEMPTS TO ADVANCE THE DEVICE THIS SIDE BUT IT COULD NOT BE ADVANCED ON THE RIGHT EITHER. THE SURGEON FELT THAT THE HYDROPHILIC COATING HAD COME OFF THE DELIVERY SYSTEM. IT WAS NOTED THAT THE PHYSICIAN HAD ACTIVATED THE HYDROCOATING AS PER THE IFU WITH A SALINE SOAKED GAUZE. A NEW VALIANT STENT GRAFT WAS OPENED AND WAS SUCCESSFULLY DEPLOYED VIA THE PATIENTS RIGHT SIDE AND THE PROCEDURE COMPLETED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO CALCIFIED VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7572606 ↗
• InjuryFeb 27, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE. IT WAS REPORTED THAT, APPROXIMATELY 1.5 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE ER. A CT SHOWED THAT THE VALIANT STENT GRAFT HAD MIGRATED 7CM FURTHER UP INTO THE THORACIC AORTA, LEADING TO ANEURYSM GROWTH AND A SLOW TYPE IB ENDOLEAK. INTERVENTION WAS CARRIED OUT ON THE SAME DATE, 2 X VALIANT STENT GRAFT SYSTEMS WERE IMPLANTED WITHOUT INCIDENT TO COVER THE OBSERVED RUPTURE AND TO COVER DOWN AS FAR AS THE CELIAC ARTERIES, WHERE THE INITIAL STENT GRAFT SYSTEM HAD ORIGINALLY BEEN IMPLANTED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO ANGULATION IN THE DISTAL THORACIC AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 7298721 ↗
• InjuryDec 19, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CT PERFORMED THERE WAS SUSPICION OF TYPE 1B OR TYPE II ENDOLEAK. A DISTAL EXTENSION(40X40X150) WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT SUSTAINED A FALL AND A CT WAS PERFORMED. AN INCIDENTAL FINDING ON THE CT PERFORMED, REVEALED THE TYPE IB AND/OR A TYPE II ENDOLEAK HAD NOT RESOLVED. THE PHYSICIAN PLANNED TO EXTEND FARTHER DISTALLY TO THE CELIAC ARTERY. A 40X40X100MM VALIANT STENT GRAFT WAS IMPLANTED SUCCESSFULLY WITH SATISFACTORY RESULTS AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO TORTUOUS DISTAL AORTA ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7127929 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 100-120MM MM DISSECTION. IT WAS REPORTED THAT, APPROXIMATELY 1 MONTH POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY CHEST PAIN AND UPPER BACK PAIN. CT WAS PERFORMED THE NEXT DAY AND THIS SHOWED A PENETRATING ULCER PRESENT JUST BELOW THE PREVIOUSLY IMPLANTED VALIANT STENT GRAFT. A TEVAR WAS PERFORMED 2 DAYS LATER WITH DEPLOYMENT OF A VALIANT 42X42X150 WHICH COVERED THE AFFECTED AREA. NO ENDOLEAKS WERE OBSERVED AND THE PATIENT SUFFERED NO PARAPLEGIA DURING THE PROCEDURE. IT WAS REPORTED THAT, AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNDETERMINED BUT DID NOT FEEL THE PAU IS DIRECTLY RELATED TO THE PREVIOUS VALIANT STENT GRAFT PLACEMENT. FOLLOW UP CT COMPLETED APPROXIMATELY 1 WEEK POST RE-INTERVENTION REPORTED NO ENDOLEAKS AND SHOWED SUFFICIENT OVERLAP WITH THE PREVIOUS PLACED STENT GRAFT. ALL PRE-OPERATIVE PATIENT SYMPTOMS HAVE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain; Ulceration

  MAUDE report 7047886 ↗
• InjuryJun 12, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6CM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THERE APPEARED TO BE A TYPE IB ENDOLEAK ON CT SCAN. THE PHYSICIAN BROUGHT THE PATIENT BACK TO OR AND ANGIOGRAPHY DID SHOW AN ENDOLEAK BUT IT¿S SOURCE WAS NOT DETERMINED. THE PHYSICIAN PLACED A VALIANT MAIN 2CM DISTAL TO ORIGINAL VALIANT DEVICE THIS RESOLVED THE ENDOLEAK. THE PHYSICIAN IS STILL UNSURE IF IT WAS A TYPE IB OR TYPE III. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6635784 ↗
• InjuryMay 18, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PENETRATING AORTIC ULCER. IT WAS REPORTED THAT A FOLLOW-UP CT SHOWED A PROXIMAL TYPE I ENDOLEAK AND THE PAU HAS GROWN TO 6.2CM. THE PATIENT HAS A BOVINE ARCH AND THE ORIGINAL GRAFT COVERED THE SUBCLAVIAN. A CAROTID SUBCLAVIAN BYPASS WAS DONE AT THE ORIGINAL PROCEDURE. THE SUBCLAVIAN WAS COILED. THERE WAS 18MM FROM THE BRACHIOCEPHALIC TO THE PROXIMAL EDGE OF THE 36X36X200. THE DECISION WAS MADE TO PLACE A VALIANT CAPTIVIA TO SEAL THE TYPE I ENDOLEAK. THE GRAFT WAS PLACED AT THE INTENDED LOCATION AND A RELIANT BALLOON WAS USED. THE TYPE I ENDOLEAK WAS STILL FILLING AT THE END OF THE PROCEDURE. THE PHYSICIAN BALLOONED MULTIPLE TIMES WITH NO SUCCESS. IT WAS NOTED THAT THE PATIENT WAS ABLE TO MOVE THEIR EXTREMITIES AT THE END OF THE PROCEDURE. THE PATIENT WAS STABLE AND OTHERWISE SYMPTOM FREE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION VS GRAFT NOT OPPOSING WALL DUE TO BARE STENTS ON PREVIOUS PLACED GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6575890 ↗
• InjuryMar 21, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 300 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED 3 TIMES TO THE ER WITH BACK AND ARM PAIN. A CT REVEALED THAT THE FALSE LUMEN WAS FILLING. BECAUSE THIS WAS THE THIRD TIME THE PATIENT PRESENTED, THEIR PHYSICIAN DECIDED TO EXTEND THE VALIANT DEVICE. A 36X32X150 DEVICE WAS IMPLANTED DOWN TO THE CELIAC ARTERY. DURING THE PROCEDURE, NO ANGIOGRAMS WERE PERFORMED. IT WAS NOTED THAT THE FALSE LUMEN WAS STILL VISUALIZED USING INTRAVASCULAR ULTRASOUND. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND THE EVENT RESOLVED. THE PATIENT COULD MOVE THEIR LEGS AND WAS REPORTEDLY RECOVERING WELL. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6422323 ↗