VALIANT® Captivia VAMC4040C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169346833), received between Jun 21, 2017 and Jun 24, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT 2 WEEKS LATER INTERVENTION WAS PERFORMED WHERE ARCH VESSEL REVASCULARIZATION DUE TO ASCENDING AORTIC ANEURYSM . GRAFT EXTENSION WAS CARRIED OUT USING NON-MEDTRONIC DEVICES THE PATIENT WAS HOSPITALISED A MONTH LATER. THE PATIENT HAD LEUKOCYTOSIS AND A CT SUGGESTED POTENTIAL ENDOLEAKS AT MODULAR ATTACHMENT SITES. NO INTERVENTION WAS PERFORMED DUE TO PREVIOUS RAPID DEGENERATION. INFECTION IS NOT SUSPECTED REGARDING THE DEVICE OR PROCEDURE. PATIENT DID HAVE PNEUMONIA WHICH DOES NOT SEEM RELATED. PATIENT STATUS IS ¿NOT RECOVERED/NOT RESOLVED¿. THE SITE, SPONSOR AND INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE.

  Patient problems: Aneurysm expansion

  MAUDE report 22317864 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. TWO 12 FRENCH SHEATHS WERE UTILIZED DURING THE INDEX PROCEDURE. THE PATIENT UNDERWENT TEVAR FOR THE CHRONIC TYPE A DISSECTION WITH ANEURYSMAL DEGENERATION OPERATION AFTER 2ND AAA, BUT THIS DID NOT SEAL OFF ALL THE FENESTRATIONS WITH THE ARCH VESSELS. THE PATIENT WAS OFFERED AN ENDOVASCULAR OFF-LABEL AORTIC ARCH REPAIR. THE HIGH-RISK SURGERY WAS COMPLETE WITH NO EVIDENCE OF AN ENDOLEAK. THE PATIENT RECOVERED APPROX. 20 DAYS POST INDEX PROCEDURE. THE SITE ASSESSED THE TYPE A AORTIC DISSECTION AS HAVING NO RELATIONSHIP TO THE STUDY DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. THE SPONSOR ASSESSED THE TYPE A AORTIC DISSECTION AS POSSIBLE RELATED TO PROCEDURE, NOT RELATED TO DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 21909497 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE INTENDED TO BE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 40MM THORACIC AORTIC ANEURYSM.. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE IMPLANTING  VAM4040C150TU THE PHYSICIAN WAS ADVANCING THE DELIVERY SYSTEM WHEN THE WIRE RETRACTED AND THE RIGHT ILIAC ARTERY RUPTURED AND THE STENT WENT THROUGH THE WALL OF THE COMMON ILIAC ARTERY. THE CASE WAS RESOLVED WITH IMPLANTATION OF COVERED ILIAC STENTS.  AS PER THE PHYSICIAN THE CAUSE OF THIS EVENT WAS DUE TO THE PATIENTS OWN ANATOMY DUE TO TORTUOUS ILIACS.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 13001553 ↗
• InjuryMay 11, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, AN ENDOLEAK TYPE 1A WAS NOTED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED

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

  MAUDE report 11806355 ↗
• InjuryAug 6, 2019Leak/Splash; Leak/Splash

  A VALIANT MONA LSA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 72 MM THORACIC AORTIC ANEURYSM . A VALIANT CAPTIVIA STENT GRAFT WAS ALSO IMPLANTED DISTALLY AND OVERLAPPING WITH THE VALIANT MONA LSA DURING THE PROCEDURE. IT WAS REPORTED THAT SOME ANEURYSM GROWTH WAS OBSERVED BY THE SITE THREE YEARS LATER. IT WAS REPORTED THAT A TYPE IA AND TYPE IB ENDOLEAK WAS NOTED BY THE SITE ON (B)(6) 2018 WITH ENLARGEMENT OF THE DISTAL END OF THE COMMERCIAL VALIANT STENT GRAFT OBSERVED TO BE RESULTING IN LOSS OF SEAL AND THE TYPE IB ENDOLEAK. IT WAS REPORTED THAT A YEAR LATER THE PATIENT PRESENTED EMERGENTLY WITH ACUTE ONSET ABDOMINAL PAIN. THE SOURCE OF THE PAIN COULD NOT BE IDENTIFIED. THE PATIENT WAS ADMITTED AND EXPERIENCED SOME CHEST PAIN AND SHORTNESS OF BREATH. THE SOURCE OF THESE COMPLAINTS COULD ALSO NOT BE IDENTIFIED. THE EVENT WAS REPORTED BY THE SPONSOR TO BE POSSIBLY DEVICE RELATED AND BY THE INVESTIGATOR TO NOT BE RELATED TO DEVICE OR PROCEDURE. A SECONDARY PROCEDURE WAS CARRIED OUT ONE WEEK LATER TO REPAIR ANEURYSM EXPANSION WITH THE ADDITION OF A VALIANT STENT GRAFT DISTALLY AND OTHER NON MDT STENT IN THE SMA AND RENAL ARTERIES. THIS INTERVENT

  Patient problems: Dyspnea; Injury; Pain

  MAUDE report 8863753 ↗
• 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 7127928 ↗
• MalfunctionJun 21, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 75MM DIAMETER THORACIC AORTIC ANEURYSM. THE DISTAL NECK IS 20MM IN LENGTH AND IT IS 36MM, 29MM, 36MM IN DIAMETER FROM PROXIMAL TO DISTAL, IRREGULAR SHAPED. IT WAS REPORTED THAT AFTER REVIEW OF THE FOLLOW-UP CT IT WAS DETERMINED THAT THE PATIENT MOST LIKELY HAS A DISTAL TYPE I ENDOLEAK. THE PATIENT HAS NOT AND WILL NOT RECEIVE TREATMENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED, SHORT DISTAL SEAL ZONE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6659144 ↗