VALIANT® Captivia VAMF3838C200TU (UDI 00643169346550)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169346550), received between Feb 28, 2017 and Mar 21, 2025 — classified as 7 deaths, 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM . ADDITIONALLY, AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED THE SAME DAY. APPROX. 1 YEAR AND 2 MONTHS POST INDEX PROCEDURE, A VALIANT NAVION STENT GRAFT WAS IMPLANTED ALONG WITH AN ADDITIONAL ENDURANT LIMB. IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED EMERGENTLY EXPERIENCING CHEST AND BACK PAIN. CT IMAGING REVEALED A TYPE IA ENDOLEAK, A TYPE IB ENDOLEAK, AND A TYPE III ENDOLEAK, THOUGH NO RUPTURE WAS OBSERVED. THE PATIENT UNDERWENT RELINING WITH A NON-MDT THORACIC GRAFT. THE RELINING OF THE GRAFTS WAS SUCCESSFUL, BUT MULTIPLE COMPLICATIONS AROSE DURING THE PROCEDURE, INCLUDING A LACERATED BOWEL DUE TO ANESTHESIA-RELATED ISSUES, AND PNEUMONIA. THESE COMPLICATIONS ULTIM ATELY LED TO THE PATIENT¿S DEATH 10 DAYS LATER. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS AND GRAFT ISSUES WAS UNKNOWN. AN AUTOPSY REVEALED SIX HOLES IN THE IN THE OUTERMOST VALIANT CAPTIVIA STENT GRAFT WHICH APPEARED TO BE CAUSED BY THE INNER FREE FLOW GRAFT¿S BARE METAL RUBBING THROUGH THE OUTER GRAFT. THE CAUSE OF DEATH WAS DUE TO MULTIPLE COMPLICATIONS FROM THE PROCEDURE INCLUDING THE LA

  Patient problems: Back pain; Bowel Perforation; Chest Pain; Pneumonia

  MAUDE report 21661760 ↗
• DeathOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED ONE DAY POST INDEX PROCEDURE, THE PATIENT SUFFERED A STROKE, WHICH WAS RESOLVED WITH THROMBOLYTICS. HOWEVER, THE NEXT DAY, THE PATIENT EXPERIENCED A SPONTANEOUS RETROGRADE TYPE A DISSECTION (RTAD) AND EXPIRED. PER THE PHYSICIAN THE CAUSE DEATH WAS DUE TO THE RTAD ALTHOUGH THE CAUSE OF THE RTAD ITSELF REMAINS UNDETERMINED. THE PHYSICIAN BELIEVED THE SIZING OF THE VALIANT CAPTIVIA DEVICES WAS APPROPRIATE AND DID NOT ATTRIBUTE THE RTAD TO DEVICE SIZING.

  Patient problems: Stroke/CVA; Vascular Dissection

  MAUDE report 20381816 ↗
• InjuryOct 9, 2023Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A TAA ON AN UNKNOWN DATE . IT WAS REPORTED THAT A VAM F3636C200TU WAS PLACED PROXIMALLY AT THE LEFT SUBCLAVIAN AND EXTENDED WITH A VAMF4040C150TU. IT WAS REPORTED ON AN UNKNOWN DATE OF A CT, AN ENDOLEAK WAS IDENTIFIED. IT WAS CONFIRMED THAT BOTH THE PROXIMAL AND DISTAL SEAL ZONES WERE ADEQUATE AND THE ENDOLEAK WAS AT THE MID PORTION OF THE GRAFT AT THE OVERLAP BY THE PROXIMAL BARE STENTS OF THE EXTENDED GRAFT.  INTERVENTION WAS PERFORMED THE FOLLOWING DAY. THE PLAN WAS TO PLACE A VAMF3838C200TU PROXIMALLY AND EXTEND WITH A VAMC4040C150TU. FEMORAL ACCESS WAS GAINED VIA THE RIGHT GROIN AND A PIGTAIL WAS PLACED UP TO THE LEVEL OF THE OVERLAP ZONE. THE TYPE III ENDOLEAK COULD CLEARLY BE SEEN ON ANGIOGRAM.  FIRST THE VAMF3838C200TU WAS INTRODUCED , THERE WAS DIFFICULTY PASSING THE DELIVERY SYSTEM ACROSS THE COMMON ILIAC ARTERY DUE TO TIGHT CALCIFIED VESSELS. AFTER MULTIPLE PASSES WITH DILATORS AND SHEATHS , THE DELIVERY SYSTEM WAS ABLE TO REACH THE DESIRED LOCATION AND THE STENT GRAFT WAS DEPLOYED.   AFTER THE TIP CAPTURE WAS RELEASED , THE PHYSICIAN PULLED THE GREY TRIGGER WHILE HOLDING THE SLIDER HANDLE STA

  Patient problems: Perforation of Vessels

  MAUDE report 17894135 ↗
• InjuryOct 6, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  TAA .  IT WAS REPORTED ON AN UNKNOWN FOLLOW-UP VISIT , IT WAS NOTED THE PATIENTS ANEURYSM HAD ENLARGED FROM 45MM TO 80MM . THE SIZE OF THE TAA CAUSED PRESSURE ON THE PATIENTS ESOPHAGUS.  A CT PERFORMED AND A REVIEWED BY A RADIOLOGIST DETERMINED THERE WAS A TYPE III AND IB ENDOLEAK PRESENT.  INTERVENTION WAS PERFORMED, THE PATIENT WAS BROUGHT TO OR. A TYPE IB ENDOLEAK WAS NOTED THEREFORE A NON MDT STENT GRAFT WAS IMPLANTED AS A DISTAL EXTENSION.  THE PHYSICIAN NOTED A POSSIBLE FRACTURE IN VAMF3838C200TU CAUSING TYPE III ENDOLEAK. THIS STENT GRAFT WAS ALSO RELINED WITH A NON MDT STENT GRAFT.  PER THE PHYSICIAN,  THE CAUSE OF THE TYPE III ENDOLEAK WAS NOTED TO BE THE FRACTURE AND THE CAUSE OF THE IB ENDOLEAK WAS NOTED AS TAA ENLARGEMENT.  NO ADDITIONAL CLINICAL SEQUALE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17887010 ↗
• InjuryAug 16, 2023Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM.  IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN. CT SHOWED WHAT APPEARED TO BE A HOLE IN THE GRAFT. ON (B)(6) 2023 INTERVENTION WAS COMPLETED. ANOTHER VALIANT CAPTIVIA STENT WAS IMPLANTED TO RELINE THE GRAFT AND  RESOLVE THE ENDOLEAK.  PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17555530 ↗
• InjuryMay 29, 2023Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT A TAA. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TO THE ER APPROXIMATELY 6 YEARS AND 5 MONTHS POST INDEX PROCEDURE WITH CHEST PAIN. A STAT CT SHOWED A TYPE IIIA ENDOLEAK. A RUPTURED ANEURYSM OF 90MM WAS NOTED. THE 38X200 VALIANT CAPTIVIA STENT GRAFT HAD PULLED OUT OF THE PROXIMAL MOST 34X200 VALIANT CAPTIVIA STENT GRAFT CREATING A LEAK THAT RE PRESSURIZED THE SAC. THE PATIENT WAS BROUGHT FOR INTERVENTION THE FOLLOWING MORNING. TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED TO BRIDGE THE TWO DISLODGED PIECES FIXING THE IIIA ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE IIIA ENDOLEAK WAS ANATOMY AND DUE TO ELONGATION OF THE AORTA AFTER THE INITIAL REPAIR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 17016489 ↗
• MalfunctionMar 8, 2023Defective Component; Positioning Problem; Defective Component; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM TAA. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GAP BETWEEN THE TIP AND THE GRAFT COVER COULD NOT BE PUSHED TOGETHER. THE GRAFT COULD NOT BE DELIVERED. ANOTHER STENT GRAFT WAS IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THE TIP AND THE GRAFT COVER GAP COULD NOT BE PUSHED TOGETHER. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501483 ↗
• DeathSep 8, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A CHRONIC 85 & 67 MM TAA AND > 300 MM THORACIC AORTIC DISSECTION. DEBRANCHING OF THE ARCH VESSELS WAS ALSO PERFORMED. IT WAS REPORTED THE PROCEDURE WAS PERFORMED WITH NO TECHNICAL DIFFICULTY.  IT WAS REPORTED 3 DAYS POST-OPERATIVELY, THE PATIENT HAD BLEEDING IN THE THORACIC AREA. THE PATIENT SUBSEQUENTLY EXPIRED ON THE SAME DATE DUE TO THE BLEEDING BEFORE ANY INTERVENTION COULD BE CARRIED OUT. PERTHE PHYSICIAN IT IS BELIEVED THERE WAS A THERE WAS A TYPE IB ENDOLEAK AND A LEAK THAT CAUSED THE BLEEDING. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15377650 ↗
• InjuryApr 23, 2021Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA AND NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67.8MM X 78.5MM THORACIC ANEURYSM. APPROX. 1 YEAR 8 MONTHS POST INDEX, AN ADDITIONAL 2 VALIANT NAVION DEVICES WERE IMPLANTED FOR AN UNKNOWN PROCEDURE IT WAS REPORTED THE CORE LAB OBSERVED THE FOLLOWING AFTER ANALYSIS OF THE 12M, INTERIM & 24M CTS: TYPE IIIB ENDOLEAK OF (B)(4) VALIANT CAPTIVIA DEVICE & TYPE IIIA ENDOLEAK BETWEEN (B)(4) AND (B)(4) NAVION DEVICES. MOREOVER, 7 STENT FRACTURES (6 FRACTURES IN MOST DISTAL STENT AND 1 FRACTURE IN SECOND MOST DISTAL STENT) & STENT ENLARGEMENT IN SECOND STENT RING OF (B)(4) NAVION DEVICE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11714964 ↗
• InjuryOct 11, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY ONE YEARS POST THE INDEX PROCEDURE, CT SHOWED A TYPE IA ENDOLEAK. INTERVENTION WAS WITH A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS AND A FURTHER TEVAR PROCEDURE WAS COMPLETED TO RESOLVE THE EVENT. VNMF3737C97TU WAS DEPLOYED DISTAL TO THE LEFT CAROTID ARTERY AND VNMF4040C103TU WAS THEN USED TO BRIDGE THE 37 X 37 X 97. COILING OF THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY WAS COMPLETED DURING THE INDEX PROCEDURE. IT WAS REPORTED POST THE REINTERVENTION PROCEDURE THE PATIENT HAD SEVERAL BLOOD PRESSURE RELATED ISSUES AND HAD SUFFERED A STROKE. THE PATIENT WAS TRANSFERRED TO IR WHERE THE ORIGIN OF THE LEFT CAROTID ARTERY WAS STENTED. SEVERAL ANGIOGRAMS SHOWED NO OBVIOUS SIGNS OF INTERCRANIAL THROMBUS. PER THE PHYSICIAN THE CAUSE OF THE LOSS OF SEAL IS UNDETERMINED. THE CAUSE OF THE STROKE WAS RELATED TO UNSTABLE BLOOD PRESSURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Stroke/CVA

  MAUDE report 9178284 ↗
• InjuryOct 19, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF UNKNOWN SIZE ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT RECEIVED RE-INTERVENTION (VALIANT CAPTIVIA AND ENDOANCHORS) TO CORRECT A TYPE IA AND A TYPE IB ENDOLEAK AND MIGRATION. THE EVENTS WERE RESOLVED AND THE PATIENT WAS DISCHARGED FROM HOSPITAL. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7984449 ↗
• InjuryOct 15, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 80MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT A TYPE IA ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS COMPLETED WHERE AN ADDITIONAL VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT TO RESOLVE THE ENDOLEAK. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS DUE TO DISEASE PROGRESSION AND THE PATIENTS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7964605 ↗
• InjuryOct 12, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS BEING IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM UP TO THE RIGHT ILIAC BIFURCATION USING A 20FR SHEATH HOWEVER AFTER SEVERAL FAILED ATTEMPTS TO ADVANCE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND REPLACED THE SHEATH TO A 14FR. ANGIOGRAPHY WAS PERFORMED WHERE PLAQUE DISRUPTION OF THE EXTERNAL ILIACS AND FILLING DEFECTS IN THE SUPERFICIAL AND DEEP FEMORAL ARTERIES WAS IDENTIFIED AND A POSSIBLE DISSECTION OF THE EXTERNAL ARTERY. USING A 6FR SHEATH ANGIO WAS CONTINUED AND THE PHYSICIAN DETERMINED THAT THE PLAQUE DISRUPTION OR POSSIBLE DISSECTION OF THE EXTERNAL ILIAC WAS NOT FLOW LIMITING AND THEREFORE DID NOT REQUIRE TREATMENT. A FEMORAL ARTERY ENDARTECTOMY AND THROMBECTOMY WAS PERFORMED TO REMOVE THE OCCLUSION AND THE EVENT RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT DUE TO CALCIFIED PLAQUE THAT EMOBLISED IN THE EXTERNAL ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection; Occlusion

  MAUDE report 7960368 ↗
• MalfunctionSep 24, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A 4 YEAR CT SCAN IDENTIFIED A TYPE IA ENDOLEAK. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS PATIENT ANATOMY DUE TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901327 ↗
• DeathJul 23, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION OF ON. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY AND WAS TREATED WITH A VALIANT STENT GRAFT AND SUBSEQUENT LASER FENESTRATION FROM THE ARM VIA THE LSA; HOWEVER, DUE TO ANATOMY, THE LASER WAS UNSUCCESSFUL IN REACHING THE APPROPRIATE SITE. IT WAS REPORTED THE PATIENT WAS STABLE UPON COMPLETION OF THE PROCEDURE HOWEVER EXPIRED ONE DAY POST THE INDEX PROCEDURE DUE TO DISSECTION. PER THE PHYSICIAN THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Intimal Dissection; Vascular Dissection

  MAUDE report 7709711 ↗
• MalfunctionMay 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A 80MM THORACIC ABDOMINAL AORTIC ANEURYSM WHICH WAS 254MM IN LENGTH. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH DIFFICULTY SWALLOWING. A CHEST CT REVEALED SIGNIFICANT EXPANSION OF THE PATIENTS ANEURYSM WITH NO OBVIOUS EVIDENCE OF AN ENDOLEAK. THE 3D RECON REVEALED THE GRAFT HAS MIGRATED DISTAL TO ORIGINAL IMPLANT POSITION AND THERE WAS A LARGE EXPANSION OF THE MID DESCENDING THORACIC AORTA. THE PHYSICIAN REPORTED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7506110 ↗
• DeathApr 19, 2018Difficult To Position; Difficult to Remove; Difficult To Position; Difficult to Remove

  A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THAT A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 90MM THORACIC AORTIC ANEURYSM. AN ANEURYSM HAD REPORTEDLY DEVELOPED ABOVE AND BELOW THE PREVIOUSLY IMPLANTED TALENT STENT GRAFT. DURING THE PROCEDURE, ACCESS WAS BY RIGHT SUBCLAVIAN CUTDOWN. THE DEVICE WAS NOT LONG ENOUGH TO GET TO THE INNOMINATE ARTERY DUE TO TORTUOUS VESSELS. THE PHYSICIAN DEPLOYED THE DEVICE WITHOUT THE NOSE CONE INTO THE INNOMINATE ARTERY. UPON TRYING TO REMOVE THE DEVICE, THE TOP CAP BECAME STUCK ON THE FREE FLOW STENTS. WHILE TRYING TO REMOVE THE DEVICE THE PATIENT CRASHED AND EXPIRED. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE PATIENT ANATOMY RELATED DUE TO TORTUOUS VESSELS.

  Patient problems: Death

  MAUDE report 7442414 ↗
• InjuryFeb 20, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM (300MM IN LENGTH FROM THE LSA TO SMA). IT WAS REPORTED THAT ON FOLLOW UP CT A TYPE IA ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO ANGULATION OF THE VESSEL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7282112 ↗
• MalfunctionJan 19, 2018Difficult to Remove; Difficult to Remove

  TWO VALIANT THORACIC STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN INTRAMURAL HEMATOMA WITH DISSECTION AND PENETRATING ATHEROSCLEROTIC ULCER. A 24 FR SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE AFTER THE SECOND STENT GRAFT HAD BEEN DELIVERED SUCCESSFULLY (B)(4), THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM OUT OF THE 24 FR SENTRANT SHEATH. THE PHYSICIAN REPORTED THAT WHILE REMOVING THE DELIVERY SYSTEM FROM THE SHEATH THE PHYSICIAN MET RESISTANCE, IT WAS NOTED BY THE REP THAT ¿THE PHYSICIAN WAS PULLING ON THE GRAFT COVER INSTEAD OF THE GREY HANDLE TO EXTRACT THE SYSTEM FROM THE SHEATH¿. ONCE THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE SHEATH HE NOTICED THAT THE TIP OF THE GRAFT COVER WAS MOVED OVER AND CAUGHT ON THE SIDE OF THE SPINDLE THAT HOUSES THE FREE FLOW STENTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7205053 ↗
• InjuryJun 29, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A RECENT FOLLOW UP APPOINTMENT THE CT DEMONSTRATED A PROXIMAL TYPE I ENDOLEAK ON THE INFERIOR ASPECT OF THE AORTIC ARCH. THE PATIENT HAD A CAROTID SUBCLAVIAN BYPASS 2 DAYS AGO AND THE LEFT SUBCLAVIAN ARTERY WAS LIGATED PROXIMAL TO THE BYPASS. THE PHYSICIAN IMPLANTED FOUR HELI-FX ENDOANCHORS ON THE INFERIOR ASPECT OF THE CURVE AND TWO HELI-FX ENDOANCHORS ON THE SUPERIOR ASPECT OF THE CURVE. A VALIANT 42X150 STENT GRAFT WAS IMPLANTED EXTENDING INTO THE LEFT CAROTID ARTERY ORIGIN. THE FOLLOW UP ANGIOGRAPHY SHOWED THAT THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSES OF THE EVENTS WERE RELATED TO THE STENT GRAFT SIZE DISCREPANCY; OVERSIZED AND ANATOMY RELATED, ANATOMICAL ANGLE OF THE AORTIC NECK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6677568 ↗
• DeathJun 2, 2017Occlusion Within Device; Occlusion Within Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH DEAD BOWEL. THE CT REVEALED THAT THE THORACIC AORTA WAS CLOTTED WITHIN THE VALIANT STENT GRAFT. AN OPEN REPAIR WAS ATTEMPTED BUT THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY AND THE OCCLUSION/CLOT MAY HAVE STARTED AT THE BEND OF THE VALIANT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Ischemia; Occlusion

  MAUDE report 6608418 ↗
• InjuryApr 28, 2017Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THERE WAS SEVERE CALCIFICATION IN THE PROXIMAL AORTIC NECK. THE PATIENT¿S VESSELS WERE FRAIL. THERE WAS THROMBUS AND CALCIFICATION AT THE PROXIMAL AND DISTAL IMPLANTATION SITE. THE DIAMETER OF THE ACCESS VESSEL MEASURED 7 MM. THE LEFT SIDE WAS SLIGHTLY LESS STENOTIC IN THE ILIAC ARTERY BUT HAD SOME ANGULATION. IT WAS REPORTED THAT THE PRE-OPERATIVE CT DID NOT EXTEND BELOW ILIAC BIFURCATION. THREE MONTHS EARLIER THE PHYSICIAN ATTEMPTED TO ACCESS THE VESSELS HOWEVER DUE TO AN UNSEEN BARE METAL STENTS BILATERALLY IN THE FEMORAL ARTERY THE PHYSICIAN COULD NOT GAIN ACCESS. NO MEDTRONIC PRODUCTS WERE USED AT THAT TIME. THE FOLLOWING WEEK THE PATIENT HAD A LSA-CAROTID BYPASS. CURRENTLY, THE PHYSICIAN ELECTED TO INSERT ANOTHER MANUFACTURER¿S 8 MM CONDUIT. HOWEVER, THE VALIANT STENT GRAFT DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE 8-MM CONDUIT AND WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. THE PHYSICIAN REMOVED THE 8-MM CONDUIT AND REPLACED IT WITH A HEMISHIELD 10-MM CONDUIT DIRECTLY TO THE AORTA. THE VALIANT STENT GRAFT DELIVERY SYSTEM WAS RE-INSE

  Patient problems: Blood Loss; Cardiac Arrest; Myocardial Infarction; Perforation of Vessels

  MAUDE report 6531213 ↗
• DeathFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR ENDOVASCULAR TREATMENT OF A 65 MM MAX DIAMETER THORACIC AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK DIAMETER RANGED FROM 36-33 MM ALONG A 39 MM LENGTH. THE DISTAL AORTA DIAMETER MEASURED ~ 39 MM. THE PATIENT HAS A STEEP AND ANGULATED AORTIC ARCH. IT WAS REPORTED THAT AFTER THE IMPLANT PROCEDURE, THE PATIENT EXPIRED DUE TO A POSSIBLE ANEURYSM RUPTURE. PER THE PHYSICIAN, THE CAUSE OF THE ANEURYSM RUPTURE LEADING TO PATIENT DEATH WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 6365357 ↗