VALIANT® Captivia VAMC3430C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169346871), received between Oct 5, 2018 and Nov 16, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC IMH WITH A HEMOTHORAX. THE 34X30X150 WAS IMPLANTED JUST DISTAL TO LEFT SUBCLAVIAN ARTERY WHILE THE OTHER VALIANT CAPTIVIA WAS IMPLANTED JUST PROXIMAL TO THE CELIAC WITH GOOD OVERLAP. 1 YEAR AND 10 MONTHS LATER , THE PATIENT WAS DIAGNOSED WITH A TYPE B AORTIC DISSECTION WHICH HAD EXTENDED PROXIMALLY INTO THORACO-ABDOMINAL AORTA, AND DISTALLY INTO ILIAC ARTERIES. THE PATIENT HAD PRESENTED WITH LLE LIMB ISCHEMIA SECONDARY TO THE DISSECTION AS WELL AS CHEST AND BACK PAIN. THEREFORE AS TREATMENT A 34X34X97 VALIANT NAVION STENT GRAFT WAS IMPLANTED OVERLAPPING THE PROXIMAL CAPTIVIA STENT GRAFT. AN ENDURANT II AUI WAS IMPLANTED AND EXTENDED WITH TWO ENDURANT LIMBS INTO THE RIGHT ILIAC ARTERY. THREE YEARS AND NINE MONTHS LATER, THE PATIENT PRESENTED EMERGENTLY WITH ALTERED MENTAL STATUS. A CT OF THE HEAD AND NECK WAS PERFORMED AS WELL AS A CT OF THE CHEST/ABDOMEN WITH CONTRAST. THE HEAD/NECK CT SHOWED THE FOLLOWING; THERE IS CONTRAST OPACIFICATION EXTENDING INTO THE INTRAMURAL HEMATOMA ON POSTCONTRAST IMAGES AT THE LEVEL OF THE DISTAL ASCENDING AORTA. THIS AREA HAS PROGRESSIVELY FI

  Patient problems: Ischemia; Pain; Vascular Dissection

  MAUDE report 18150281 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT 3 DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH A RETROGRADE TYPE A AORTIC DISSECTION. EMERGENT TREATMENT WAS PERFORMED AND THE PATIENT UNDERWENT AN ASCENDING AORTIC REPAIR. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 11990793 ↗
• InjuryDec 13, 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 DISTAL DILATION WAS NOT ASSOCIATED WITH THE PROXIMAL DEVICE, BUT RATHER WAS ASSOCIATED WITH THE DISTAL VALIANT CAPTIVIA VAMC3430C150 ((B)(4)). THE VALIANT NAVION STENT GRAFT WAS IMPLANTED AS A DISTAL EXTENSION OF THIS DEVICE. 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. IT WAS REPORTED THAT THE PHYSICIAN STATED THERE WAS A SMALL EVIDENCE OF CONTRAST ALONG THE INNER CURVE AT THE TIME OF THE ORIGINAL IMPLANT BUT THE CONTRAST WASN¿T EVIDENT IN THE ANEURYSM SAC. THEY OBSERVED A SMALL GAP ALONG THE INNER CURVE ON THE CURRENT CT, SUGGESTING THE VALUE OF SECURING THE GRAFT TO THE INNER CURVE TO MITIGATE ENDOTENSION. THE ENDOANCHORS WERE PLANNED TO BE PLACED ALONG THE LESSER CURVE OF THE AORTA AT THE PROXIMAL MARGIN OF THE PRIOR VALIANT CAPTIVIA

  Patient problems: Injury

  MAUDE report 9466799 ↗
• InjuryApr 11, 2019Leak/Splash; Leak/Splash

  AN UNKNOWN STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PAU. A VALIANT STENT GRAFT WAS IMPLANTED DISTALLY TO TREAT A SMALL EXTENSION OF THE DISSECTION APPROXIMATELY TWO MONTHS LATER. IT WAS REPORTED THE PATIENT PHONED TECHNICAL SERVICES TO REPORT VESSEL PRESSURE ASSOCIATED WITH THE VALIANT STENT GRAFT. AS PER THE PHYSICIAN AN EXTENSION DUE A DISTAL INTIMA TEAR WAS SEEN IN THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Intimal Dissection

  MAUDE report 8503047 ↗
• InjuryOct 5, 2018Adverse 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 >200MM DISSECTION. IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE THAT THE PATIENT SUFFERED FROM PARALYSIS POST THE CSF DRAIN REMOVAL. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 7938141 ↗