VALIANT® Captivia VAMF3434C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169347366), received between Dec 1, 2016 and Jul 16, 2025 — classified as 5 deaths, 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 16, 2025Difficult to Insert; Difficult to Remove; Defective Component; Material Deformation; Difficult to Insert; Difficult to Remove; Defective Component; Material Deformation

  A VALIANT CAPTIVIA (VAMF3434C200TU) WAS USED ALONG WITH A SENTRANT SHEATH (SENSH2428W) ON TO A TREAT A LOSS OF SEAL AND MIGRATION OF A NON-MEDTRONIC STENT GRAFT IMPLANTED 10 DAYS PRIOR. THE VALIANT CAPTIVIA WAS INSPECTED PRIOR TO USE AND A GAP WAS NOTED BETWEEN THE TIP AND THE GRAFT COVER. THE PHYSICIAN STILL PROCEEDED TO USE IT. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE AND THE HYDROPHILIC COATING WAS ACTIVATED WITH SALINE. DURING THE PROCEDURE, THE SENTRANT SHEATH WAS INSERTED WITHOUT ISSUE. IT WAS REPORTED THAT WHEN ATTEMPTING TO INSERT THE VALIANT CAPTIVIA STENT GRAFT DELIVERY SYSTEM INTO THE SENTRANT SHEATH, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE DELIVERY SYSTEM WAS PULLED BACK AND THE GAP WAS STILL OBSERVED. THIS IRREGULARITY COULD NOT BE CORRECTED DESPITE MANIPULATION OF THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO GET THE DEVICE IN AND DEPLOY THE STENT GRAFT WITHOUT ISSUE. THERE WAS RESISTANCE AGAIN WHEN PULLING THE DEVICE OUT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE OBSERVED GAP. ADDITIONALLY, IT WAS NOTED THAT THE TIP OF THE VALIANT CAPTIVIA DELIVERY SYSTEM GRAFT DID NOT APPEAR SMOOTH. THE PHYSICIAN HYPOTHESIZED THAT THE ISSUE WAS ISOLAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517257 ↗
• InjuryFeb 13, 2024Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, A VALIANT NAVION STENT GRAFT WAS IMPLANTED DUE TO A FAILURE IN THE DISTAL SEAL OF THE PREVIOUSLY IMPLANTED DISTAL VALIANT CAPTIVIA STENT GRAFT. THE FAILURE WAS DUE TO DISEASE PROGRESSION AND THE NAVION STENT GRAFT WAS IMPLANTED DISTALLY. IT WAS REPORTED FOLLOW UP CT APPROXIMATELY 4 YEARS POST THE NAVION IMPLANT SHOWED THE DISTAL NAVION GRAFT IS NO LONGER INTACT. THE STENT IS FRACTURED AND NO LONGER APPEARS TO BE ATTACHED TO ANYTHING. THE DISTAL SEAL IS GONE WITH A SUSPECTED TYPE IB ENDOLEAK. ANEURYSM EXPANSION WAS OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE LOSS OF SEAL IN THE VALIANT CAPTIVIA WAS DUE TO DISEASE PROGRESSION. THE FRACTURE AND ENDOLEAK TO THE NAVION GRAFT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2024 SHOWS A NEW TYPE IB ENDOLEAK IN THE NAVION GRAFT VNMC4343C175U. 2 POSSIBLE STENT FRACTURES ON THE 2 MOST DISTAL RINGS OF (B)(6) WERE OBSERVED (UNABLE TO CONFIRM DUE TO IMAGE QUALITY). NEW STENT RING E

  Patient problems: Insufficient Information

  MAUDE report 18693737 ↗
• MalfunctionDec 1, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED DURING AN ENDOVASCULAR PROCEDURE IN ORDER TO PLACE ENDOANCHORS IN AN EXISTING VALIANT CAPTIVIA GRAFT.  IT WAS REPORTED DURING THE INDEX PROCEDURE ONE ENDOANCHOR DID NOT PENETRATE THE AORTIC WALL AND BECAME LOOSE IN THE DESCENDING AORTA. THE PHYSICIAN PLACED ANOTHER GRAFT (VAMF4646C100TU) OVER IT TO HOLD IT IN PLACE AND THE ISSUE WAS RESOLVED. IT WAS CONFIRMED THAT THE ENDOANCHORS WERE IMPLANTED TO TREAT A TYPE IA ENDOLEAK IN AN EXISTING VALIANT STENT GRAFT . PER THE PHYSICIAN THE CAUSE OF TYPE IA ENDOLEAK IS UNDETERMINED IT WAS REPORTED A TYPE IA ENDOLEAK WAS SEEN ON CT 18 MONTHS LATER . PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK COULD NOT BE DETERMINED. IT WAS NOTED THE VAMF4646C100TU AND THE 46X46X150 ARE IMPLANTED PROXIMALLY WHILE THE 40X40X200 IS IMPLANTED DISTALLY. IT WAS CONFIRMED THE TYPE IA ENDOLEAK IS CONTAINED IN THE PROXIMAL STENT GRAFT VAMF4646C150TU. THE FOLLOWING MONTH TWO VALIANT CAPTIVIA STENT GRAFTS VAMF3434C200TU/ (B)(6) VAMC4040C150TU/ (B)(6) WERE IMPLANTED TO TREAT THE TYPE IA ENDOLEAK. ON THE FINAL ANGIOGRAM NO ENDOLEAKS WERE OBSERVED. TWO DAYS LATER, AN UNKNOWN ENDOLEAK WAS SEEN ON SCAN. AS PER THE PHYSICIAN THE

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245651 ↗
• DeathJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 200MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED 2 DAYS POST THE INDEX PROCEDURE, WHILE THE PATIENT WAS STILL AN INPATIENT A DISSECTION INTO THE ASCENDING AORTA HAD OCCURRED SOMETIME POST THE INDEX PROCEDURE. THE PATIENT EXPIRED 2 DAYS POST THE INDEX PROCEDURE AS A RESULT OF THE DISSECTION. PER THE PHYSICIAN THE CAUSE OF THE DISSECTION IS UNDETERMINED.

  Patient problems: Vascular Dissection

  MAUDE report 16245711 ↗
• MalfunctionJan 18, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION ON (B)(6) 2020. IT WAS REPORTED BY THE PATIENTS WIFE REPORTED THAT THE PATIENT HAS UNDERGONE AN ADDITIONAL VASCULAR SURGERYVALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION. IT WAS REPORTED BY THE PATIENTS WIFE REPORTED THAT THE PATIENT HAS UNDERGONE AN ADDITIONAL VASCULAR SURGERY APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. 2 VALIANT CAPTIVIA AND 3 ENDURANT STENT GRAFTS WERE IMPLANTED. CTA FINDINGS FROM APPROXIMATELY 32 MONTHS POST THE INDEX PROCEDURE SHOWED FALSE LUMEN PERFUSION. COMPARED TO CT EXAMINATION 26 MONTHS POST THE INDEX PROCEDURE SHOWS THERE REMAINS ENDOLEAK'S ABOUT THE AORTOILIAC BIFURCATION. THE NATIVE AORTA ABOUT THIS LEVEL REMAINS RELATIVELY UNCHANGED IN DIMENSION, CURRENTLY MEASURING 51 X 47 MM IN THE TRANSVERSE AND AP DIMENSIONS RESPECTIVELY. THERE ARE ADDITIONAL ENDOLEAK'S ABOUT THE DISTAL DESCENDING THORACIC AORTA AT THE LEVEL OF THE DIAPHRAGMATIC CRUS. LEFT COMMON ILIAC-SMA, AND LEFT COMMON ILIAC-BILATERAL RENAL ARTERY DEBRANCHED BYPASS GRAFTS REMAIN WIDELY PATENT. THERE IS GOOD VISCERAL PERF

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193701 ↗
• MalfunctionJan 6, 2023Defective Component; Defective Component

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR REPAIR AN UNKNOWN GRAFT IMPLANTED FOR A THORACIC ANEURYSM. ( THE DATE OF THE IMPLANT OF THE GRAFT IS UNKNOWN). IT WAS REPORTED DURING THE INDEX PROCEDURE THE VALIANT DEVICE WOULD NOT TRACK THROUGH THE ILIAC ARTERIES DUE TO A LARGE GAP BETWEEN THE NOSE CONE AND GRAFT COVER. A NON MDT GRAFT WAS USED TO RELINE THE EXISTING GRAFT AND THE PROCEDURE COMPLETED. PER THE PHYSICIAN THE CAUSE WAS DUE TO A GAP BETWEEN THE STENT GRAFT COVER AND NOSE CONE WHICH PREVENTED THE DEVICE FROM TRACKING THROUGH THE ILLIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111292 ↗
• InjuryFeb 4, 2022Leak/Splash; Leak/Splash

  AN ENDURANT II AORTIC EXTENSION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 75MM ABDOMINAL AORTIC ANEURYSM ON THE (B)(6) 2014. A VALIANT CAPTIVIA STENT WAS IMPLANTED APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED THAT THE PATIENT RETURNED FOR FOLLOW-UP 2 MONTHS POST THE VALIANT PROCEDURE WHERE AN UNKNOWN ENDOLEAK WAS DISCOVERED. THE PHYSICIAN TREATED THE ENDOLEAK WITH BY PERFORMING A TAAA REPAIR THE FOLLOWING DAY IMPLANTING AN ADDITIONAL VALIANT STENT GRAFT AND ENDURANT STENT GRAFT SYSTEM AND THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN WAS UNSURE IF THE EVENT WAS DUE TO A TYPE III ENDOLEAK OR A FAILURE IN THE PREVIOUSLY IMPLANTED VALIANT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13450094 ↗
• InjuryJan 19, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE . A FOLLOW-UP CT FROM 3 MONTHS AFTER THE INDEX PROCEDURE SHOWED THE PRESENCE OF A TYPE IB ENDOLEAK WHICH WAS MONITORED IN FURTHER FOLLOW-UP CT'S. A SECONDARY PROCEDURE WAS PERFORMED 2 YEARS POST INDEX PROCEDURE WHERE A VALIANT NAVION WAS IMPLANTED IN ORDER TO TREAT THE TYPE IB ENDOLEAK. A CT CARRIED OUT ON THE 4 MONTHS AFTER THE INTERVENTION SHOWED NO PRESENCE OF ENDOLEAK. IT WAS NOTED THAT THE THORACIC AORTIC ANEURYSM HAD NOW REACHED A DIAMETER OF 67MM. NO CAUSE OF THE TYPE IB ENDOLEAK AS BE THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13289553 ↗
• InjuryJun 29, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED APPROXIMATELY 45 MONTHS POST PROCEDURE, WHERE AN ENDOLEAK TYPE 1A WAS OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12084594 ↗
• InjurySep 30, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ENDOLEAK. IT WAS REPORTED THAT APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, A CT WAS PERFORMED WHERE IT WAS NOTED A POSSIBLY ENDOLEAK IIIB OR A JUNCTION LEAK BETWEEN TWO GRAFTS. IT WAS STATED THAT THE LOCATION OF THE ENDOLEAK WAS UNKNOWN. THE EVENT WAS TREATED BY IMPLANTING A VNMC3737C223TU AND VNMC3737C182TU INSIDE THE ORIGINAL GRAFTS. NO ENDOLEAK NOTED DURING FINAL ANGIOGRAM. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10605141 ↗
• InjuryDec 3, 2019Leak/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. IT WAS REPORTED THAT APPROXIMATELY 2 YEARS 8 MONTHS POST INDEX PROCEDURE, DUE TO DISTAL AORTIC DILATION A VALIANT NAVION STENT GRAFT WAS IMPLANTED AS AN EXTENSION. THE PHYSICIAN ELECTED TO IMPLANT ENDOANCHORS DUE TO A POSSIBLE TYPE IA ENDOLEAK OBSERVED AT THE VERY PROXIMAL MARGIN HOWEVER IT WAS NOTED THAT THE ENDOLEAK DID NOT APPEAR TO BE FILLING THE SAC. THE ENDOANCHORS WERE PLANNED TO BE PLACED ALONG THE LESSER CURVE OF THE AORTA AT THE PROXIMAL MARGIN OF THE PRIOR VALIANT CAPTIVIA IMPLANT DISTAL TO THE LCC/LSA. DURING PLACEMENT OF THE ENDOANCHOR, IT WAS INITIALLY DEPLOYED AND PENETRATED THE FABRIC. THE SECOND PHASE OF DEPLOYMENT WAS PERFORMED BUT THE ENDOANCHOR DISLODGED AND REMAINED SUSPENDED IN THE ARCH FOR A FEW SECONDS BEFORE DISAPPEARING INTO THE RCC OR LCC. 8 ADDITIONAL ENDOANCHORS WERE PLACED IN TOTAL, 7 SUCCESSFULLY AS PLANNED. THE 6TH ENDOANCHOR WAS NOT DEPLOYED SUCCESSFULLY. AS PER THE PHYSICIAN, THE CAUSE WAS PRODUCT RELATED. THE CAUSE OF THE TYPE IA ENDOLEAK WAS NOT CONFIRMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIE

  Patient problems: Injury

  MAUDE report 9401363 ↗
• InjuryApr 3, 2019Defective Component; Defective Component

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS INTENDED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED 77 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE A VAMF3434C200TU. HOWEVER, WHEN THE DEVICE WAS OPENED A SEPARATION WAS NOTED BETWEEN THE GRAFT COVER AND THE TIP OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO CLOSE THE SEPARATION AND USE THE DEVICE, BUT WAS UNABLE TO INSERT THE DEVICE INTO THE PATIENT'S FEMORAL ARTERY. IT WAS REPORTED THAT THE PHYSICIAN COULD SEE WHERE THE GRAFT COVER WAS CATCHING DUE TO THE SEPARATION. A SECOND VAMF3434C200TU DEVICE WAS THEN OPENED, BUT THE SAME SEPARATION ISSUE WAS NOTED AND THE DEVICE COULD NOT BE TRACKED INTO THE PATIENT'S FEMORAL ARTERY. A VALIANT NAVION DEVICE (VNMF3737C229TU) WAS THEN INSERTED AND IMPLANTED WITHOUT ANY ISSUE. WHEN THE NAVION DELIVERY SYSTEM WAS REMOVED, THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ANGIOGRAM SHOWED THAT THE RIGHT EXTERNAL ILIAC WAS RUPTURED. THE INJURED AREA WAS TREATED WITH A 8 MM NON-MEDTRONIC STENT. IT WAS REPORTED THAT THE PHYSICIAN STATED THAT THE RUPTURE OF THE EXTERNAL ILIAC OCCURRED WHEN TRYING TO INSERT THE VALIA

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 8478646 ↗
• DeathJan 23, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A CONTAINED 60MM RUPTURED THORACIC ANEURYSM. THE PATIENT HAD A KNOWN THORACIC ANEURYSM. THE ACCESS VESSEL WAS REPORTED TO BE VERY NARROW. IT WAS REPORTED DURING THE INDEX PROCEDURE DUE TO TIGHT ACCESS THE PHYSICIAN ELECTED TO PERFORM A ENDOCONDUIT WITH 3 NON MDT STENTS PLACING THEM FROM THE MID RIGHT COMMON ILIAC TO JUST ABOVE THE INGUINAL LIGAMENT. IT WAS NOTED BILATERAL ILIAC STENTS WERE PREVIOUSLY IMPLANTED AND ONE STENT WAS PLACED INSIDE AN EXISTING STENT AND BALLOONING COMPLETED. THE PHYSICIAN ATTEMPTED TO INSERT THE VALIANT STENT GRAFT BUT IT WOULD NOT PASS ANY FURTHER THAN THE TIP OF THE NOSE CONE DUE TO SIZE OF EXTERNAL ILIAC. AT THIS POINT OF THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN PERFORMED A RETROGRADE INJECTION THROUGH THE 11FR. SHEATH IN PLACE AND OBSERVED EXTRAVASATION FROM THE EXTERNAL ILIAC WHERE THE NON MDT STENTS HAD BEEN PLACED. UNCONTROLLABLE BLOOD LOSS WAS REPORTED AND CPR COMMENCED. WHILE CPR WAS IN PROGRESS THE PHYSICIAN MADE A LONGER INCISION AND OBSERVED THAT THE ENTIRE EXTERNAL ILIAC WAS TORN UP TO THE AREA OF THE RIGH

  Patient problems: Blood Loss; Cardiac Arrest; Death

  MAUDE report 8270734 ↗
• InjuryMay 14, 2018Difficult To Position; Difficult To Position

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PASS THE VALIANT CAPTIVIA STENT GRAFT SYSTEM (B)(4) INTO THE MAIN RIGHT FEMORAL ARTERY AND WAS UNABLE TO GET THE DEVICE TO THE DESIRED LOCATION. THE ACCESS VESSEL SIZE WAS REPORTED TO BE 8-9MM AND NON-CALCIFIED. MULTIPLE ATTEMPTS WERE MADE BUT THE GRAFT COULD NOT PASS. ANOTHER MANUFACTURERS 24 FRENCH SHEATH WAS THEN PASSED THROUGH THE ACCESS VESSEL AND THE VESSEL DISSECTED. A NON-MDT STENT GRAFT WAS IMPLANTED TO RESOLVE THE DISSECTION AND THE CASE WAS ABORTED. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE EVENT TO THE PATIENTS ANATOMY AND REPORTED THAT ACCESS WAS EXTREMELY DIFFICULT. THE DIFFICULTY WITH ACCESS WAS NOT EXPECTED DUE TO THE SIZE OF THE ACCESS VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Perforation of Vessels

  MAUDE report 7510015 ↗
• InjuryApr 4, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 80MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 4 YEARS POST INDEX PROCEDURE. A TYPE III ENDOLEAK WAS DISCOVERED ON A CT SCAN. THE PATIENT WAS VISITING FROM MICHIGAN, WHERE THE ORIGINAL STENT GRAFT HAD BEEN IMPLANTED, WHEN HE STARTED EXPERIENCING THE BACK PAIN. THE PHYSICIAN DID A BRACHIAL AND FEMORAL ARTERY EXPOSURE AND A VAMF3838C200TE WAS IMPLANTED INSIDE OF THE EXISTING GRAFTS TO COVER THE TYPE III ENDOLEAK. THE GRAFTS WERE REPAIRED. NO FURTHER CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7395070 ↗
• DeathDec 8, 2017Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION OF 450 -500MM. IT WAS REPORTED THAT TWO DAYS POST PROCEDURE A FOLLOW UP CT REVEALED THAT THE VISCERAL VESSELS HAD DEVELOPED COMPROMISED BLOOD FLOW. THIS LED TO LIMITED BLOOD FLOW TO THE VISCERAL VESSELS, RESULTING IN ISCHEMIA TO THE TISSUE AND BLOOD SUPPLY TO THE ORGANS. IT WAS REPORTED THAT THE PATIENT EXPIRED 2 DAYS POST INDEX PROCEDURE FROM ABDOMINAL ISCHEMIA. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO INACCURATE IMPLANTATION OF THE STENT GRAFT, THE PROXIMAL PORTION OF THE STENT GRAFT WAS IN THE TRUE LUMEN; HOWEVER THE DISTAL PORTION OF THE STENT GRAFT WAS IN THE FALSE LUMEN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Ischemia; Occlusion

  MAUDE report 7099281 ↗
• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEMS WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 60 MM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED A SENTRANT SHEATH WAS USED FOR DELIVERY OF THE VALIANT STENT GRAFT SYSTEM. THERE WERE DIFFICULTIES DURING THE ADVANCEMENT OF THE SENTRANT SHEATH AND IN GAINING ACCESS TO THE COMMON ILIAC ARTERY. PER THE PHYSICIAN THE CAUSE OF THE INSERTION DIFFICULTIES WAS ANATOMY RELATED, DUE TO TISSUE DEGRADATION AND VESSEL DIAMETER. IT WAS REPORTED THAT POST INDEX PROCEDURE BUT ON THE SAME DAY, A RUPTURED ILIAC ARTERY WAS DISCOVERED. THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER¿S SELF-EXPANDING STENTS, AND COVERED STENTS TO EXCLUDE THE VESSEL RUPTURE. POST INDEX PROCEDURE THE PATIENT ALSO SUFFERED A CVA/STROKE. AS PER THE PHYSICIAN, THE CAUSE OF THE STROKE CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 6995634 ↗
• DeathSep 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 THE ENDOVASCULAR TREATMENT OF A 240MM THORACIC DISSECTION ON (B)(6) 2017. IT WAS REPORTED THAT TWO DAYS POST OP, THE PATIENT HAD AN AORTIC ASCENDING DISSECTION AND RUPTURE AFTER THE TEVAR PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2017. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED HOWEVER, WAS MOST LIKELY RELATED TO THE PROCEDURE.

  Patient problems: Death; Rupture; Vascular Dissection

  MAUDE report 6899951 ↗
• InjurySep 6, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENT EMERGENTLY WITH CHEST PAIN. A CT SHOWED THAT THERE WAS AN UNKNOWN ENDOLEAK, EITHER A TYPE I ENDOLEAK OR A TYPE III SEPARATION ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT TWO ADDITIONAL VALIANT STENT GRAFTS, MODELED THE STENT GRAFTS WITH A BALLOON AND THE UNKNOWN ENDOLEAK WAS RESOLVED. 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: Injury; Pain

  MAUDE report 6844243 ↗
• DeathJul 5, 2017Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A CHRONIC TYPE B DISSECTION THAT HAS TURNED INTO A 6.3 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PHYSICIAN ELECTED TO PERFORM A RIGHT CAROTID TO LEFT CAROTID TO LEFT SUBCLAVIAN ARTERY BYPASS, EMBOLIZATION OF THE LSA, AND LIGATION OF THE LCCA PRIOR TO INSERTION OF THE VALIANT STENT GRAFT. IT WAS REPORTED THAT THERE WERE DIFFICULTIES ADVANCING THE VALIANT STENT GRAFT TO THE INTENDED LANDING ZONE DUE TO THE PATIENT¿S SEVERELY TORTUOUS AORTA AND TIGHTNESS OF THE THORACIC AORTA ARCH. DURING THE DEPLOYMENT OF THE VALIANT DEVICE, THE NOSE CONE CAUGHT ON ANOTHER MANUFACTURER¿S OCCLUSION DEVICE IN THE LSA AND DISLODGED IT INTO THE ASCENDING THORACIC AORTA. THE OCCLUSION DEVICE MADE IT UP INTO THE THORACIC ARCH, WHERE THE PHYSICIAN DEPLOYED THE VALIANT STENT GRAFT CAPTURING THE OCCLUSIVE DEVICE BETWEEN THE VALIANT STENT GRAFT AND THE VESSEL WALL. THE VALIANT STENT GRAFT WAS COMPLETELY DEPLOYED LANDING THE PROXIMAL END DISTAL THE INNOMINATE ARTERY. DURING THE RECAPTURE OF THE NOSE CONE, THE NOSE CONE WOULD NOT GO THROUGH THE VALIANT STENT GRAFT DUE TO THE TIGHTNESS AND ANGLE OF THORACIC ARCH. THE PHYS

  Patient problems: Death; Vascular Dissection

  MAUDE report 6688461 ↗
• InjuryMay 30, 2017Kinked; Device Damaged by Another Device; Kinked; Device Damaged by Another Device

  A VALIANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER THORACIC AORTIC ANEURYSM. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR USE AS A CONDUIT IN THE RIGHT ILIAC LIMB. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE VALIANT 34X34X150 DELIVERY SYSTEM TO THE INTENDED LANDING ZONE DUE TO CALCIFICATION. THE VALIANT 34X34X150 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X10X124 RIGHT ILIAC LIMB IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES AS A CONDUIT. THE PHYSICIAN USED ANOTHER MANUFACTURER¿S 12X4 BALLOON IN THE ENDURANT STENT GRAFT AND PERFORMED AN ANGIOPLASTY. THE PHYSICIAN RE-INSERTED THE VALIANT 34X34X150 ONCE AGAIN, BUT WAS UNABLE TO ADVANCE THE DEVICE, THE PHYSICIAN NOTICED THAT THE NOSE CONE HAD BEEN DAMAGED WITH WHAT APPEARED TO BE A BURR ON THE END. THE DEVICE WAS DISCARDED. THE PHYSICIAN INSERTED A VALIANT 34X34X200 STENT GRAFT HOWEVER WHILE ADVANCING THE DEVICE UP THE LEFT ILIAC ARTERY THERE WAS SOME FRICTION THE DEVICE THEN KINKED/BUCKLED AND THEN WAS UNABLE TO ADVANCE ANY FURTHER. THE PHYSICIAN REMOVED AND DISCARDED THE DEVICE AND ABORTED PROCEDURE. AFT

  Patient problems: Injury

  MAUDE report 6599626 ↗
• InjuryDec 15, 2016Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST INDEX PROCEDURE A CT REVEALED THAT THE VALIANT STENT GRAFT HAD A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL VALAINT STENT GRAFT AND EXTENDED COVERAGE TO THE LEVEL OF THE CELIAC TRUNK AND THE ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO UNDERSIZING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6174896 ↗
• InjuryDec 1, 2016Adverse 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 THE ENDOVASCULAR TREATMENT OF A 260 MM IN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT FIFTEEN DAYS POST INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND A BLOOD PRESSURE OF 200/104 MM HG. IT WAS DISCOVERED THAT THE PATIENT HAD AN ACUTE TYPE A DISSECTION. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR OF THE ASCENDING AORTIC ARCH AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PROXIMAL BARE SPRING OF THE VALIANT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 6138471 ↗