VALIANT CaptiviaRecalls & reported problems across all models

We found 95 models of VALIANT Captivia by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 463 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2016 and Jul 30, 2026 — classified as 109 deaths, 255 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (209 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

Most reported VALIANT Captivia problems

VALIANT Captivia models

95 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VALIANT® Captivia VAMF3838C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths23 reports
• VALIANT® Captivia VAMF3434C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths23 reports
• VALIANT® Captivia VAMF3636C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths22 reports
• VALIANT® Captivia VAMF4040C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths18 reports
• VALIANT® Captivia VAMF3838C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths17 reports
• VALIANT® Captivia VAMF4646C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths13 reports
• VALIANT® Captivia VAMF3636C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths13 reports
• VALIANT® Captivia VAMF3434C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  13 reports
• VALIANT® Captivia VAMF3232C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 deaths13 reports
• VALIANT® Captivia VAMF4646C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths11 reports
• VALIANT® Captivia VAMF3232C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 deaths10 reports
• VALIANT® Captivia VAMC3838C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• VALIANT® Captivia VAMF2828C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death9 reports
• VALIANT® Captivia VAMF3232C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths9 reports
• VALIANT® Captivia VAMC4444C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 deaths8 reports
• VALIANT® Captivia VAMF3030C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death8 reports
• VALIANT® Captivia VAMF4242C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths8 reports
• VALIANT® Captivia VAMF4242C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death7 reports
• VALIANT® Captivia VAMC4040C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• VALIANT® Captivia VAMF4040C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• VALIANT® Captivia VAMF3030C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• VALIANT® Captivia VAMF3636C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• VALIANT® Captivia VAMF3434C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths7 reports
• VALIANT® Captivia VAMF3030C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• VALIANT® Captivia VAMF2626C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• VALIANT® Captivia VAMF3632C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  7 reports
• VALIANT® Captivia VAMC3632C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• VALIANT® Captivia VAMF3838C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• VALIANT® Captivia VAMF4040C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death6 reports
• VALIANT® Captivia VAMF3430C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths6 reports
• VALIANT® Captivia VAMF4444C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths5 reports
• VALIANT® Captivia VAMC4238C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death5 reports
• VALIANT® Captivia VAMC3834C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death5 reports
• VALIANT® Captivia VAMC4242C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• VALIANT® Captivia VAMC3430C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• VALIANT® Captivia VAMF2828C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  5 reports
• VALIANT® Captivia VAMC3232C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• VALIANT® Captivia VAMC4036C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• VALIANT® Captivia VAMC4646C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• VALIANT® Captivia VAMF2626C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths4 reports
• VALIANT® Captivia VAMF2222C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 deaths4 reports
• VALIANT® Captivia VAMF3228C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• VALIANT® Captivia VAMF3834C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• VALIANT® Captivia VAMF4036C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death4 reports
• VALIANT® Captivia VAMF4238C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  4 reports
• VALIANT® Captivia VAMC4646C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• VALIANT® Captivia VAMC3434C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 deaths3 reports
• VALIANT® Captivia VAMC2824C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• VALIANT® Captivia VAMC4440C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• VALIANT® Captivia VAMC3636C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• VALIANT® Captivia VAMC4040C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• VALIANT® Captivia VAMF4646C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• VALIANT® Captivia VAMF4444C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• VALIANT® Captivia VAMF4242C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death3 reports
• VALIANT® Captivia VAMF4440C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  3 reports
• VALIANT® Captivia VAMF4040C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• VALIANT® Captivia VAMF3636C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• VALIANT® Captivia VAMC3030C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• VALIANT® Captivia VAMC2828C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMC4646C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMC3434C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMC3636C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMF4444C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMF2424C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMC3838C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMC4646B100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  2 reports
• VALIANT® Captivia VAMF3026C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• VALIANT® Captivia VAMF4642C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death2 reports
• VALIANT® Captivia VAMC3838C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3232C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC2424C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMF3838C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF3434C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF3232C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF3838C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF4040C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF4444C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC2824C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC4238C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC4444C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC3030B100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC2626C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC4642C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC4040C200TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3228C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3026C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMF2424C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMF2222C150TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC4242C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC3636C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3434C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3030C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 death1 report
• VALIANT® Captivia VAMC2828C100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC4242B100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report
• VALIANT® Captivia VAMC3434B100TU

  SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
  1 report

Recent VALIANT Captivia adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Leak/Splash; Device Damaged by Another Device

  A modified Valiant Captivia stent graft VAMF3838C150TU was implanted during the endovascular treatment of 69mm ascending thoracic aortic aneurysm in the ascending Aorta. Pt disease was a focal PAU starting in the distal aspect of Zone 2. The Physician unsheathed the VAMF3838C150TU on the back table and modified the graft according to the "Double Fenestrated Valiant Captivia" published literature creating a large fenestration "window", 25mm distal to the graft edge and then creating an 8mm wire tipped reinforced fenestration 5mm distal to the large proximal fenestration. A 260cm Glide wire was used after an 18gauage angiocath puncture of the delivery sheath to provide a "pre-cannulated wire for the LSA. The graft stent struts were systematically reconstrained with silk ties and the graft was resheathed, releasing silk ties appropriately. As planned- the pre-cannulated wire exited the tip of the device, above the graft from the LSA to edge, but "within" the graft delivery sheath. Moderate calcification of the aortic bifurcation as well as the bilateral CIA in the proximal 20mm, mild/moderate tortuosity of the CIA from the mid-proximal segment. It was reported during the index procedu

  Patient problems: Paresis; Stroke/CVA

  MAUDE report 50083887 ↗
• MalfunctionMay 27, 2026Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN INDEX THORACIC ENDOVASCULAR AORTIC PROCEDURE USING A VALIANT CAPTIVIA STENT GRAFT FOR TREATMENT OF AN ULCER, THE STENT GRAFT APPEARED TO JAM AFTER APPROXIMATELY 1CM OF DEPLOYMENT. AT THAT POINT, THE GRAFT MATERIAL HAD NOT YET BEEN EXPOSED, AND THE GRAFT COVER COULD NOT BE RETRACTED ANY FURTHER. THE PHYSICIAN ADJUSTED AND ATTEMPTED DEPLOYMENT AGAIN, BUT REMOVED THE DEVICE BEFORE FURTHER GRAFT MATERIAL WAS EXPOSED WITHOUT CAUSING DAMAGE TO THE PATIENT OR DISRUPTING THE PREVIOUS EVAR IMPLANT. A BACKUP 38 × 38 × 167 MM VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED WITH A SUCCESSFUL RESULT. POST-CASE EXAMINATION FOUND THE STENT GRAFT COVER COULD NOT BE RETRACTED BEYOND APPROXIMATELY 2 CM, AND SCREW THREADS BEGAN TO SHEAR, PRODUCING PLASTIC SHAVINGS WITHIN THE DEPLOYMENT HANDLE. THE PHYSICIAN ALLEGED A MANUFACTURING ISSUE INVOLVING THE SCREW THREADS. NO APPARENT DAMAGE TO THE OUTER BOX OR INNER PACKAGING WAS IDENTIFIED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296589 ↗
• MalfunctionMay 13, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE TO TREAT AN AORTIC ULCER, A DEPLOYMENT ISSUE OCCURRED WITH A VALIANT CAPTIVIA STENT GRAFT. NO ISSUES WERE FOUND ON THE DEVICE DURING INSPECTION PRIOR TO USE AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION AND DEPLOYMENT ATTEMPT. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS ADVANCED INTO THE THORACIC AORTA AND POSITIONED BETWEEN THE LEFT CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY. THE DEVICE REMAINED IN THE THORACIC AORTA FOR APPROXIMATELY 10-15 MINUTES PRIOR TO DEPLOYMENT WHILE THE CLINICAL TEAM ADDRESSED ISSUES WITH THE POWER INJECTOR. ONCE THE INJECTOR WAS FIXED, THE SURGEON PERFORMED AN ANGIOGRAPHIC RUN AND MARKED THE INTENDED LANDING ZONE. WHEN THE DEPLOYMENT BEGAN, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE TURNING THE BLUE DEPLOYMENT HANDLE. INCREASING DIFFICULTY WAS ENCOUNTERED WHEN ROTATING THE HANDLE AND THE SHEATH DID NOT RETRACT AS EXPECTED. THE SHEATH MAY HAVE RETRACTED APPROXIMATELY ONE TO TWO INCHES. THE PHYSICIAN THEN ATTEMPTED TO PULL THE GRAY TRIGGER ON THE DELIVERY SYSTEM BUT ALSO EXPERIENCED SIGNIFICANT DIFFICULTY. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND A DIFFERENT MEDTRONIC DEVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158125 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  THREE VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN INITIAL STAGED ENDOVASCULAR PROCEDURE TO TREAT A 70MM SYMPTOMATIC THOR ACOABDOMINAL ANEURYSM. A PRE-OPERATIVE COMPUTED TOMOGRAPHY SCAN IDENTIFIED AN OCCLUDED LEFT SUBCLAVIAN ARTERY AND BILATERAL INTERNAL ILIAC OCCLUSION, AND THE EXTERNAL ILIAC ARTERIES WERE DESCRIBED AS DISEASED AND SMALL; A HIGH RISK FOR PARALYSIS WAS DISCUSSED PRIOR TO PROCEEDING IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A 10 MM NON-MEDTRONIC STENT WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY AND BALLOONED TO 10 MM FOR GRAFT PLACEMENT, AND THE THREE VALIANT CAPTIVIA STENT GRAFTS WERE PLACED FROM THE LEVEL OF THE LEFT CAROTID ARTERY DOWN TO THE CELIAC ARTERY IN THE FOLLOWING ORDER: VAMF3834C150TU PROXIMALLY, VAMC3632C150TU MIDDLE GRAFT AND VAMC3430C150TU DISTALLY. VISCERAL VESSELS WERE PRE-STENTED FOR A PLANNED SECOND-STAGE PROCEDURE. THE PATIENT INITIALLY TOLERATED THE PROCEDURE AND THEN DEVELOPED LEG WEAKNESS WITH SOME PARTIAL PARALYSIS ONE DAY POST-OPERATIVELY. THE PATIENT RETURNED TO THE OPERATING ROOM FOR PLACEMENT OF A SPINAL DRAIN AND A CAROTID-SUBCLAVIAN BYPASS, AND WAS REPORTED TO BE GRADUALLY IMPROVING WITH SOME MOVEMENT OF THE LEGS. IT W

  Patient problems: Ischemia; Muscle Weakness/Atrophy; Paralysis

  MAUDE report 25157990 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE STENT GRAFT VAMF3030C100TU VALCAP FREFL DELIVERY SYSTEM USED IN THE TREATMENT OF AN AORTIC ULCER, THE TAPER TIP AND WIRE LUMEN ATTACHED TO THE TAPER TIP DISCONNECTED FROM THE DELIVERY SYSTEM AND REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE WIRE LUMEN AND NOSE CONE FROM THE PATIENT OVER THE DELIVERY WIRE. SIZING WORKSHEET AND 3D RECONSTRUCTION DATA INDICATED A PROXIMAL THORACIC AORTA DIAMETER OF 26MM AT IMPLANT, WITH MILD ANGULATION, TORTUOSITY, AND MODERATECALCIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER THE PHYSICIAN NO EXCESSIVE FORCE WAS NEEDED TO REMOVE THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646887 ↗
• MalfunctionMar 20, 2026Fracture

  A VALIANT CAPTIVIA STENT GRAFT VAMF3636C100TU VALCAP FREFL WAS INTENDED TO BE IMPLANTED DURING A TEVAR PROCEDURE TO TREAT A 39MM AORTIC DISSECTION. IT WAS REPORTED THAT DURING PREPARATION THE DEVICE WAS OPENED AND PRESENTED ONTO THE STERILE FIELD, WHERE THE DEVICE APPEARED DAMAGED PRIOR TO IMPLANTATION. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD AND SECURED, AND A REPLACEMENT VALIANT DEVICE WAS PROMPTLY PROVIDED. THE DAMAGED DEVICE WAS NOT IMPLANTED, AND THE PATIENT WAS NOT EXPOSED TO IT. THE PROCEDURE CONTINUED WITHOUT DELAY USING THE REPLACEMENT PRODUCT, AND THE PATIENT UNDERWENT SUCCESSFUL TEVAR FOR AORTIC DISSECTION. NO PATIENT COMPLICATIONS WERE REPORTED. THE EVENT WAS RESOLVED AS THE DAMAGED DEVICE WAS IDENTIFIED PRIOR TO IMPLANTATION AND REPLACED, WITH THE PROCEDURE COMPLETED AS PLANNED. THERE WAS NO PATIENT INVOLVED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. IT WAS NOTED THAT A SMALL DENT WAS OBSERVED TO THE DEVICE BOX BUT NO INTERNAL DAMAGE SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646869 ↗
• MalfunctionMar 18, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A THORACIC AORTIC ANEURYSM MEASURING 7.6 CM, THE STENT GRAFT VAMF46 46C200TU VALCAP FREFL WAS UNABLE TO BE PASSED FAR ENOUGH UP TO REACH THE MINIMAL OVERLAP MARKER AFTER  SUCCESSFUL DEPLOYMENT OF THE 42-38-150 PROXIMAL DEVICE. IT ADVANCED A LONG WAY BUT ONCE IT WAS NEAR THE CURVE THE DEVICE ADVANCED INTO THE APEX BUT WAS NOT ABLE TO BE ADVANCED FAR ENOUGH TO REACH THE MINIMUM OVERLAP MARKER ON THE PROXIMAL PIECE. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE VAMF4646C200TU, BUT A GAP IN THE DEVICE WAS OBSERVED, WHICH WAS BELIEVED TO CAUSE THE INABILITY TO CROSS. THE DEVICE WAS SUBSEQUENTLY REMOVED. THE PATIENT WAS TREATED WITH OTHER DEVICES THAT WERE SHORTER IN LENGTH, WHICH WERE ABLE TO TRACK MORE EASILY. THE PATIENT WAS TREATED FOR THE ANEURYSM AND THERE WAS NO INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED THAT THE NORMAL GAP OF A FEW MILLIMETERS BETWEEN THE NOSE CONE WAS OBSERVED BEFORE INSERTION BUT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PHYSICIAN FELT THAT THE SMALL GAP OF THE DEVICE WAS AWAY FROM THE NOSE CONE CAUSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629961 ↗
• InjuryFeb 26, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 55 MM ANEURYSM, WHEN VALIANT CAPTIVIA WAS REMOVED FROM THE BOX, THE TIP OF THE GRAFT COVER OF THE VALIANT CAPTIVIA STENT GRAFT DEVICE WAS NOT SMOOTHLY TRANSITIONED TO THE NOSE AND A GAP WAS OBSERVED. THE PHYSICIAN NOTED VERY TIGHT ACCESS IN THIS CASE AND EXPRESSED CONCERN THAT THE SHARP EDGE OF THE GRAFT COVER POTENTIALLY DUG INTO THE INTIMA OF THE ARTERY. TISSUE WAS OBSERVED STUCK INSIDE THE GRAFT COVER. ONE DEVICE WAS ABLE TO BE IMPLANTED, THE SECOND PROXIMAL DEVICE WAS UNABLE TO PASS THROUGH THE PATIENT ARTERY AND ENTIRE PROCEDURE WAS UNABLE TO BE FINISHED. FUTURE TREATMENT IS POSSIBLY PLANNED TO COMPLETE THE PROCEDURE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 24454878 ↗
• InjuryDec 5, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA . THE STENT GRAFT WAS IMPLANTED COVERING THE LSA AND THE PROCEDURE WAS COMPLETED AS PLANNED. TWO SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. A CT PERFORMED 31 DAYS LATER SHOWED A SMALL ENDOLEAK. THE PATIENT HAD RETROGRADE FLOW INTO THE LSA. THE PATIENT UNDERWENT COIL EMBOLIZATION A MONTH LATER. THREE DAYS POST THIS PROCEDURE , THE PATIENT PRESENTED TO ED WITH HEMATEMESIS. A CT SCAN SHOWED A PAU AT THE DISTAL AORTIC ARCH. A VALIANT CAPTIVIA WAS THEN IMPLANTED THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. A CT 10 DAYS LATER SHOWED A PERSISTENT ENDOLEAK. THE PATIENT PRESENTED TO A DIFFERENT ED FIVE DAYS LATER FOR A SECOND OPINION. THE PATIENT WAS ADMITTED AND HAD THREE STENT GRAFTS IMPLANTED. THE PATIENT WAS DISCHARGED AND FOLLOWED UP IMAGING SHOWED COMPLETE RESOLUTION OF THE ENDOLEAK. THE SPONSOR ASSESSED THE PAU AND ENDOLEAK AS POSSIBLY RELATED TO THE STENT GRAFT DEVICE, NOT RELATED TO THE STUDY PROCEDURE. THE SITE ASSESSED THE PAU AS NOT RELATED TO THE PROCEDURE. THE ENDOLEAK OBSERVED ONE MONTH AFTER THE INDEX PROCEDURE FOLLOWED BY COIL EMBOLIZATION WAS IDENTIFIED AS TYP

  Patient problems: Insufficient Information

  MAUDE report 23726339 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE VALIANT CAPTIVIA STENT GRAFTS (VAMF3030C150TU, VAMC2824C150TU AND VAMC3026C150TU) WERE IMPLANTED DURING DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT TWO WEEKS LATER, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS FOUND TO HAVE A TYPE A DISSECTION AND INTRAMURAL HEMATOMA (IMH) FOLLOWING A CT SCAN. IT WAS NOTED THAT DUE TO THE PATIENT'S PAIN, SURGICAL INTERVENTION WAS PERFORMED TWO DAYS LATER. DURING THE PROCEDURE, THE ASCENDING AORTA WAS REPAIRED WITH A VALIANT CAPTIVIA (VAMC3232C100TU) AND A SURGICAL GRAFT WAS SEWN TO THIS STENT GRAFT. THE BRACHIOCEPHALIC AND LEFT CAROTID ARTERIES WERE BYPASSED. THE LEFT SUBCLAVIAN ARTERY WAS NOTED TO BE FRIABLE AND REQUIRED LIGATION. THE PATIENT WAS TREATED FOR IMH AND TYPE A DISSECTION. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED , AWAKE, ALERT AND FOLLOWING COMMANDS. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 23690850 ↗
• DeathDec 2, 2025Adverse Event Without Identified Device or Use Problem; 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 23690807 ↗
• 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 ↗
• InjuryOct 15, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA. THE STENT GRAFT WAS IMPLANTED COVERING THE LSA AND THE PROCEDURE WAS COMPLETED AS PLANNED. TWO SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. A CT PERFORMED ONE MONTH LATER SHOWED A SMALL ENDOLEAK. THE PATIENT HAD RETROGRADE FLOW INTO THE LSA. THE PATIENT UNDERWENT COIL EMBOLIZATION A MONTH LATER. THREE DAYS LATER, THE PATIENT PRESENTED TO ED WITH HEMATEMESIS. A CT SCAN SHOWED A PAU AT THE DISTAL AORTIC ARCH. A DISTAL TEVAR EXTENSION WAS THEN IMPLANTED THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. A CT TWO WEEKS LATER SHOWED A PERSISTENT ENDOLEAK. THE PATIENT PRESENTED TO A DIFFERENT ED FIVE DAYS LATER FOR A SECOND OPINION. THE PATIENT WAS ADMITTED AND HAD THREE STENT GRAFTS IMPLANTED. THE PATIENT WAS DISCHARGED A WEEK LATER AND FOLLOWED UP IMAGING SHOWED COMPLETE RESOLUTION OF THE ENDOLEAK. THE SPONSOR ASSESSED THE PAU AND ENDOLEAK AS POSSIBLY RELATED TO THE STENT GRAFT DEVICE, NOT RELATED TO THE STUDY PROCEDURE. THE SITE ASSESSED THE PAU AS NOT RELATED TO THE PROCEDURE.

  Patient problems: Hematemesis; Pseudoaneurysm; Ulcer

  MAUDE report 23298869 ↗
• MalfunctionSep 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT VAMC2824C150TU VALCAP TAPER, THE DEVICE WOULD NOT FLUSH AND WAS LEAKING OUT OF THE BACK. THE PATIENT WAS TREATED FOR AN ULCER. A NEW GRAFT WAS OPENED AND USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052333 ↗
• MalfunctionJul 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT AN AORTIC DISSECTION MEASURING OVER 400MM IN LENGTH, THE STENT GRAFT VAMF32 32C200TU VALCAP FREFL DELIVERY SYSTEM BECAME STUCK DURING DEPLOYMENT AND THE STENT COULD NOT BE DEPLOYED. WHILE THE PHYSICIAN WAS INITIALLY ABLE TO ROTATE THE BLUE DEPLOYMENT WHEEL AND RETRACT THE SHEATH UP TO THE LEVEL OF THE BARE METAL STENTS, THE DEVICE SUBSEQUENTLY BECAME STUCK AND THE WHEEL WOULD NO LONGER TURN, AND THE SHEATH FAILED TO RETRACT. ATTEMPTS TO REVERSE THE WHEEL¿S DIRECTION IN ORDER TO FREE THE MECHANISM WERE UNSUCCESSFUL. AS A RESULT, THE DEVICE COULD NOT BE DEPLOYED AS INTENDED AND WAS REMOVED FROM THE PATIENT. A MANUFACTURING ISSUE WAS REPORTED AS THE CAUSE OF THE DEVICE MALFUNCTION BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT STENT GRAFT (VAMF3232C150TU, (B)(6), AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607317 ↗

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