VALIANT® Captivia VAMF2828C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169347090), received between Sep 4, 2017 and Jun 30, 2023 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT AND A RELIANT BALLOON WERE USED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE AS PART OF THE APV STUDY. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER ONE WEEK POST THE INDEX PROCEDURE WITH LEFT ARM SWELLING AND A HEMATOMA WAS OBSERVED AT THE LEFT BRACHIAL ARTERY SITE. THE PATIENT HAD SURGERY TO EVACUATE THE HEMATOMA. THE PATIENT WAS GIVEN MEDICATION AND BLOOD THINNERS AND THE SWELLING WENT DOWN GRADUALLY. THE CAUSE OF THE HEMATOMA IS UNDETERMINED. THE SITE ASSESSED AS NOT RELATED TO THE DEVICE AND AS HAVING A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THE SPONSOR ASSESSES THE HEMATOMA AS CAUSALLY RELATED TO THE INDEX STUDY PROCEDURE AND NOT RELATED TO THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 17237900 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A PAU. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER COMPLETING THE PROPER CHECK TO ENSURE THAT THE RIGHT GRAFT WAS SELECTED, THE BOX WAS OPENED AND THE PACKAGE SLID OUT. AFTER DOUBLE CONFIRMATION THE STAFF OPENED THE DEVICE AND THE STERILE STAFF WENT AHEAD AND PULLED THE DEVICE OUT AND PLACED IT ON THE BACK TABLE. AFTER THE DEVICE WAS OPENED IT WAS NOTICED THAT THE TOP BARE RELEASE BLUE SLIDER WAS BROKEN AND IN TWO PIECES IN THE PACKAGE. THE GRAFT WAS THEN PLACED BACK INTO THE ORIGINAL BOX AND A NEW GRAFT WAS OPENED AND IMPLANTED WITHOUT ANY PATIENT INCIDENT AND PROCEDURE BEING COMPROMISED. PER THE PHYSICIAN THE CAUSE OF THE BROKEN COMPONENT IS UNDETERMINED. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519446 ↗
• InjuryFeb 8, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY, WHERE AN ENDOLEAK TYPE 1B ENDOLEAK WAS NOTED ON THE PREVIOUSLY PLACED THORACIC GRAFT. A VALIANT NAVION STENT GRAFT WAS IMPLANTED TO TREAT THE EVENT ON THE SAME DAY. EVENT WAS RESOLVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11293069 ↗
• DeathApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TRANSECTION. IT WAS REPORTED THAT THE PATIENT DIED THE DAY AFTER THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE DEATH COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 8499695 ↗
• MalfunctionFeb 27, 2018Difficult to Remove; Difficult to Remove

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A COARCTIC THORACIC AORTA. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT AFTER IMPLANTING THE DEVICE SUCCESSFULLY, UPON REMOVAL OF THE DELIVERY SYSTEM IT APPEARED THAT THE SHEATH COVERING WAS NOT COMPLETELY CLOSED LEAVING THE INNER CORE/TIP EXPOSED. THE DELIVERY DEVICE DID NOT CLOSE PROPERLY EVEN THOUGH HANDLE AND BACK END HANDLE WERE IN CLOSED POSITION. THE PHYSICIAN HAD TO CAREFULLY REMOVE THE DELIVERY SYSTEM FROM THE ACCESS CUTDOWN RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT NO INJURY OCCURRED TO THE PATIENT AS A RESULT OF THIS EVENT. THE PHYSICIAN STATED THAT THE DEVICE WAS DEFECTIVE AS IT WOULD NOT COMPLETELY CLOSE AS ANTICIPATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298728 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A SUSPICIOUS DISRUPTION NEAR AND ABOVE A PAU (PENETRATING AORTIC ULCER). THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 24-26 MM AT IMPLANT, THE ANGULATION WAS 30 DEGREES, AND THERE WAS MODERATE CALCIFICATION PRESENT. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED ONE STENT GRAFT INITIALLY BUT AS IT LANDED TOO SHORT OF THE CELIAC ARTERY, ANOTHER 100 MM STENT GRAFT WAS PLACED JUST ABOVE THE CELIAC. FOLLOWING DEPLOYMENT THERE WAS NO LEAK PRESENT AND THE PATIENT WAS FINE. THE PHYSICIAN ALSO PLACED STENTS IN THE RIGHT COMMON AND RIGHT EXTERNAL ILIAC. IT WAS REPORTED THAT THE PATIENT HAD A DISSECTION WITH A CONTAINED RUPTURE AND AN IMH (INTRAMURAL HEMATOMA) ALL THE WAY TO THE AORTIC ROOT. THE PHYSICIAN ATTEMPTED TO IMPLANT A THIRD VALIANT BUT IT COULD NOT BE DELIVERED THROUGH THE ILIAC STENTS. THE PHYSICIAN THE PREDILATED BOTH THE RIGHT COMMON AND RIGHT EXTERNAL ILIAC STENTS, AND THEN IMPLANTED TWO VALIANT STENT GRAFTS, ONE 150 MM JUST DISTAL TO THE LSA AND ONE 100 MM OVERLAPPING INTO THE PREVIOUS 2 STENTS IMPLANTED. POST IMPLANT IMAGING SHOWED GOOD PLACEMENT AND

  Patient problems: Hematoma; Rupture; Vascular Dissection

  MAUDE report 7203252 ↗
• InjurySep 18, 2017Adverse 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 EMERGENT ENDOVASCULAR TREATMENT OF THE TRANSECTION IN THE THORACIC AORTA. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP. A PREVIOUS CT REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM A CAROTID TO SUBCLAVIAN BYPASS TO RESOLVE THE PROXIMAL TYPE I ENDOLEAK. IT WAS LATER NOTED THAT THE PROXIMAL TYPE I ENDOLEAK HAD RESOLVED WITHOUT INTERVENTION PRIOR TO THE BYPASS CONVERSION; AS THE PHYSICIAN DID NOT REVIEW THE MOST RECENT FILMS FOR THIS PATIENT. PER THE PHYSICIAN, THERE WAS A MISCOMMUNICATION REGARDING THE CORRECT FILMS REVIEWED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6871527 ↗
• MalfunctionSep 4, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 61MM DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT WAS ORIGINALLY TREATED FOR A SACCULAR ANEURYSM THAT WAS CLOSE TO THE LSA SO BYPASSES WERE NEEDED TO BE PERFORMED. THE PHYSICIAN THEN OPTED TO IMPLANT THE DEVICE LANDING DISTAL TO LCCA AND THEN USED A LASER TO BURN HOLE VIA LSA AND THEN STENTING WITH ANOTHER MANUFACTURER¿S STENT. IT WAS REPORTED THAT A FOLLOW-UP CT SHOWED AN ENDOLEAK FROM THE ATRIUM STENT WHICH WAS EXPANDING THE SACCULAR ANEURYSM. THE PHYSICIAN ELECTED TO PERFORM A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS AND EMBOLIZED THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN THEN IMPLANTED A VALIANT STENT GRAFT (28X28) PROXIMALLY LANDING DISTAL TO THE LEFT CAROTID ARTERY. BALLOON INFLATIONS WERE THEN COMPLETED WITHIN THE STENT GRAFT AND A THORACIC AORTOGRAM WAS COMPLETED TO CHECK FOR ENDOLEAKS. TWO SUBTRACTION ANGIOGRAMS WERE PERFORMED AND IT WAS REVEALED THAT THERE WAS STILL A CONTRAST BLUSH THAT THE PHYSICIAN THOUGHT WAS POSSIBLY A TYPE II ENDOLEAK. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS GIVEN PROTAMINE, THE PHYSICIAN ELECTED TO PERFORM NORMAL FOLLOW UP I N A MONTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840956 ↗
• InjurySep 4, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 61MM DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT WAS ORIGINALLY TREATED FOR A SACCULAR ANEURYSM THAT WAS CLOSE TO THE LSA SO BYPASSES WERE NEEDED TO BE PERFORMED. THE PHYSICIAN THEN OPTED TO IMPLANT THE DEVICE LANDING DISTAL TO LCCA AND THEN USED A LASER TO BURN HOLE VIA LSA AND THEN STENTING WITHANOTHER MANUFACTURER¿S STENT. IT WAS REPORTED THAT A FOLLOW-UP CT SHOWED AN ENDOLEAK FROM THE ATRIUM STENT WHICH WAS EXPANDING THE SACCULAR ANEURYSM. THE PHYSICIAN ELECTED TO PERFORM A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS AND EMBOLIZED THE OSTIUM OF THE LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN THEN IMPLANTED A VALIANT STENT GRAFT (28X28) PROXIMALLY LANDING DISTAL TO THE LEFT CAROTID ARTERY. BALLOON INFLATIONS WERE THEN COMPLETED WITHIN THE STENT GRAFT AND A THORACIC AORTOGRAM WAS COMPLETED TO CHECK FOR ENDOLEAKS. TWO SUBTRACTION ANGIOGRAMS WERE PERFORMED AND IT WAS REVEALED THAT THERE WAS STILL A CONTRAST BLUSH THAT THE PHYSICIAN THOUGHT WAS POSSIBLY A TYPE II ENDOLEAK. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS GIVEN PROTAMINE, THE PHYSICIAN ELECTED TO PERFORM NORMAL FOLLOW UP IN A MONTH

  Patient problems: Injury

  MAUDE report 6840948 ↗