VALIANT® Captivia VAMF4040C200TU (UDI 00643169346543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169346543), received between Jan 26, 2017 and Mar 21, 2023 — classified as 5 deaths, 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 18 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN THAT REQUIRED A HEART CATHETERIZATION PROCEDURE. DURING THIS PROCEDURE ON ANGIOGRAM IDENTIFIED A TYPE III ENDOLEAK. MULTIPLE VIEWS WERE TAKEN AND THE TYPE III ENDOLEAK WAS OBSERVED IN THE OVERLAP OF THE STENT GRAFT AT THE LEVEL OF THE SECOND IMPLANTED PROXIMAL MAIN. THE NEXT DAY INTERVENTION TO RE-LINE THE GRAFT WAS COMPLETED WHERE 2 ADDITIONAL VALIANT CAPTIVIA GRAFTS WERE IMPLANTED FROM THE SUBCLAVIAN DOWN TO THE CELIAC. THE POST ANGIOGRAM SHOWED NO ENDOLEAK AND THE PATIENT WAS REPORTED AS AWAKE AND ALERT POST PROCEDURE. IN REFERENCE TO THE CAUSE OF THE TYPE III ENDOLEAK, THE PHYSICIAN NOTED THAT DURING THE ORIGINAL INDEX PROCEDURE WHEN THE PATIENT PRESENTED WITH A RUPTURED THORACIC DISSECTION ONLY ONE DISTAL MAIN GRAFT WAS AVAILABLE IN STOCK. AS SUCH THE PHYSICIAN ELECTED TO PLACE A PROXIMAL MAIN INSIDE A PROXIMAL MAIN TO FIX THE RUPTURE AND IT NOW APPEARS THAT THE TYPE III ENDOLEAK WAS AT THE LEVEL OF THE SECOND IMPLANTED PROXIMAL MAIN. NO ADDITIONAL CLINICAL SEQUE

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 16580910 ↗
• DeathMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION . THE PATIENT ALSO HAD A RUPTURED AAA WHICH WAS TREATED VIA OPEN REPAIR.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE STENT GRAFTS WERE IMPLANTED WITHOUT ANY NOTED ISSUE. THE PHYSICIAN BEGAN THE OPEN REPAIR TO ADDRESS THE RUPTURED AAA. THE PATIENT THEN EXPIRED DUE TO COMPLICATIONS FROM THE OPEN AAA REPAIR.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16520322 ↗
• InjuryNov 28, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 67MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS TORN UPON INSERTION OF THE DEVICE. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED UNTIL THE PELVIS WAS OPENED AND THE BLEEDING WAS CONTROLLED. THE DAMAGED VESSEL WAS SURGICALLY REPAIRED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED TO A SMALL EXTERNAL ILIAC ARTERY. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. IT WAS REPORTED THAT THE STENT GRAFT VAMC4238C150TU/SN (B)(4) WAS NOT IMPLANTED IN THE PATIENT. ANOTHER STENT GRAFT WAS OPENED AND DEPLOYED. THERE WERE NO ISSUES WITH ANY OTHER GRAFTS USED THAT DAY.

  Patient problems: Insufficient Information

  MAUDE report 15868028 ↗
• DeathOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 175MM THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS TRANSPORTED TO THE ICU AFTER BLOOD PRESSURE STARTED TO DROP. A NON-CONTRASTED CT WAS PERFORMED WHICH DID NOT DEMONSTRATE ANY INTERNAL PROBLEM BUT THE PATENTS CONDITION CONTINUED TO WORSEN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE THE CHEST AND ABDOMEN WERE OPENED. THE PHYSICIAN NOTICED THAT THE THORACIC ABDOMINAL AORTA HAD RUPTURED. THE PHYSICIAN DECIDED TO EXTEND THE EXISTING VALIANT GRAFT DISTALLY TO THE LEVEL OF THE CELIAC AND COMPLETE AN OPEN SURGICAL REPAIR ON ANOTHER DATE. IT WAS NOTED THAT THE PATIENT'S THORACIC ANATOMY WAS EXTREMELY TORTUOUS WITH 3 ACUTE BENDS AND THE PHYSICIAN HAD A VERY DIFFICULT TIME GETTING THE VALIANT GRAFTS TO TRACK IN THE AORTA. DURING THE SURGERY, THE PHYSICIAN NOTICED A LARGE FENESTRATION FROM THE TRUE LUMEN TO THE FALSE. THE PATIENT'S FALSE LUMEN WAS VERY LARGE AND ANEURYSMAL (SIZE NOT KNOWN). THE PHYSICIAN COMPLETED BALLOONING OF THE GRAFT AT THE LEVEL OF THE CELIAC. IT WAS REPORTED THE PATIENT EXPIRED ON THE (B)(6) 2022. PER THE PHYSICIAN THE

  Patient problems: Insufficient Information

  MAUDE report 15649091 ↗
• DeathOct 21, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 175MM THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS TRANSPORTED TO THE ICU AFTER BLOOD PRESSURE STARTED TO DROP. A NON-CONTRASTED CT WAS PERFORMED WHICH DID NOT DEMONSTRATE ANY INTERNAL PROBLEM BUT THE PATENTS CONDITION CONTINUED TO WORSEN. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WHERE THE CHEST AND ABDOMEN WERE OPENED. THE PHYSICIAN NOTICED THAT THE THORACIC ABDOMINAL AORTA HAD RUPTURED. THE PHYSICIAN DECIDED TO EXTEND THE EXISTING VALIANT GRAFT DISTALLY TO THE LEVEL OF THE CELIAC AND COMPLETE AN OPEN SURGICAL REPAIR ON ANOTHER DATE. IT WAS NOTED THAT THE PATIENT'S THORACIC ANATOMY WAS EXTREMELY TORTUOUS WITH 3 ACUTE BENDS AND THE PHYSICIAN HAD A VERY DIFFICULT TIME GETTING THE VALIANT GRAFTS TO TRACK IN THE AORTA. DURING THE SURGERY, THE PHYSICIAN NOTICED A LARGE FENESTRATION FROM THE TRUE LUMEN TO THE FALSE. THE PATIENT'S FALSE LUMEN WAS VERY LARGE AND ANEURYSMAL (SIZE NOT KNOWN). THE PHYSICIAN COMPLETED BALLOONING OF THE GRAFT AT THE LEVEL OF THE CELIAC. IT WAS REPORTED THE PATIENT EXPIRED ON THE (B)(6) 2022. PER THE PHYSICIAN THE

  Patient problems: Insufficient Information; Low Blood Pressure/ Hypotension; Rupture

  MAUDE report 15649063 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM TAA.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP ABOUT 18 MONTHS LATER, AFTER REVIEW OF THE PATIENT'S CT SCAN, THE PATIENT WAS COMPLAINING OF PAIN AND IT MAY BE THAT THE PATIENT'S PAIN IS COMING FROM EXPANSION OF THE TRUE LUMEN DUE TO STENT PLACEMENT. DESPITE SOME RETROGRADE FILLING INTO THE FALSE LUMEN, THE RESIDUAL ANEURYSM SAC IS STABLE. THERE IS A SMALL, STABLE PSEUDOANEURYSM.  1 YEAR LATER, IT WAS NOTED ON IMAGING THAT THERE IS THERE IS RETROGRADE FILLING INTO THE FALSE LUMEN- WHICH IS WORSE/ BRIGHTER THAN ON PRIOR IMAGING. THIS FILLING HAS LED TO A SMALL AMOUNT OF EXPANSION OF THE FALSE LUMEN FROM 5.3CM TO 5.6CM OVER A YEAR. THERE IS ALSO A NEW OUTPOUCHING WITHIN THE FALSE LUMEN AT THE DISTAL ASPECT OF THE STENT. A FURTHER 2 DAYS LATER, THE PATIENT WAS NOTED TO HAVE ALWAYS HAD PAIN BUT SAYS ITS WORSE THAN A YEAR BEFORE. THE PAIN GOT WORSE GRADUALLY AND NOW THE PATIENT  DOES HAVE EPISODES OF SEVERE PAIN. THE PATIENT COMPLAINS OF PAIN AT THE ANATOMICAL SITE OF THIS NEW OUTPOUCHING. THE PAIN HAS SIGNIFICANTLY AFFECTED THE PATIENTS  QUALITY OF LIFE AND MENTAL HEALTH. THE RESIDUAL ANEUR

  Patient problems: Pain; Paresis

  MAUDE report 15624933 ↗
• MalfunctionJun 21, 2022Malposition of Device; Material Deformation; Positioning Problem; Malposition of Device; Material Deformation; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED WHILE 3 OTHER VALIANT CAPTIVIA STENT GRAFTS WERE INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM DESCENDING  THORACIC AORTIC ANEURYSM VIA PERCUTANEOUS APPROACH. IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED PROBLEMS GETTING THE DEVICE TO TRACK TO THE INTENDED LANDING ZONE. THE PATIENT HAS A BOVINE ARCH AND THE INTENDED LANDING ZONE WAS AT THE ORIGIN OF THE BRACHIOCEPHALIC ARTERY. MULTIPLE ATTEMPTS WERE MADE TO PASS THE DEVICE WITHOUT ANY LUCK. THE DEVICE WOULD MAKE IT TO THE LEFT SUBCLAVIAN BUT WOULD NEVER PASS AROUND THE ARCH. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN THEN  CAME FROM THE RIGHT ARM TO BODY FLOSS AND STILL HAD THE SAME ISSUE NOT ABLE TO GET THE DEVICE TO TRACKAROUND THE ARCH. AT THIS POINT THE PHYSICIAN  DEPLOYED A VALIANT CAPTIVIA  WELL BELOW THE INTENDED LANDING ZONE TO SEE IF THAT WOULD PROVIDE MORE SUPPORT TO GET A NEW DEVICE AROUND THE ARCH TO THE INTENDED LANDING ZONE AND THE VAMF4040C200TU LOT #V30682555 WAS THEN SUCCESSFULLY IMPLANTED.  3 OTHER VALIANT CAPTIVIA'S (#V30682553 #V30731110T#V30580527) WERE OPENED AND ALL 3 KINKED TRYING TO GET THEM AROUND THE ARCH. EACH DEVICE HAD THE SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754094 ↗
• MalfunctionJun 21, 2022Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED WHILE 3 OTHER VALIANT CAPTIVIA STENT GRAFTS WERE INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM DESCENDING  THORACIC AORTIC ANEURYSM VIA PERCUTANEOUS APPROACH. IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED PROBLEMS GETTING THE DEVICE TO TRACK TO THE INTENDED LANDING ZONE. THE PATIENT HAS A BOVINE ARCH AND THE INTENDED LANDING ZONE WAS AT THE ORIGIN OF THE BRACHIOCEPHALIC ARTERY. MULTIPLE ATTEMPTS WERE MADE TO PASS THE DEVICE WITHOUT ANY LUCK. THE DEVICE WOULD MAKE IT TO THE LEFT SUBCLAVIAN BUT WOULD NEVER PASS AROUND THE ARCH. AFTER MULTIPLE ATTEMPTS THE PHYSICIAN THEN  CAME FROM THE RIGHT ARM TO BODY FLOSS AND STILL HAD THE SAME ISSUE NOT ABLE TO GET THE DEVICE TO TRACKAROUND THE ARCH. AT THIS POINT THE PHYSICIAN  DEPLOYED A VALIANT CAPTIVIA  WELL BELOW THE INTENDED LANDING ZONE TO SEE IF THAT WOULD PROVIDE MORE SUPPORT TO GET A NEW DEVICE AROUND THE ARCH TO THE INTENDED LANDING ZONE AND THE VAMF4040C200TU LOT # (B)(4)WAS THEN SUCCESSFULLY IMPLANTED.  3 OTHER VALIANT CAPTIVIA'S (# (B)(4)) WERE OPENED AND ALL 3 KINKED TRYING TO GET THEM AROUND THE ARCH. EACH DEVICE HAD THE SAME PROBLEM KINKING GOING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754074 ↗
• DeathJul 21, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANOTHER VALIANT STENT GRAFT WAS THEN IMPLANTED JUST OVER A MONTH LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY OVER 3 YEARS LATER OUTSIDE THE HOSPITAL WITH COMPLAINTS OF EPIGASTRIC PAIN. A CT WAS THEN PERFORMED WHICH REVEALED A 90 MM RUPTURED ANEURYSM AND A TYPE III ENDOLEAK WHICH LOOKED TO BE COMING FROM THE OVERLAP BETWEEN STENTS. INTERVENTION WAS PERFORMED WHERE 2 X VALIANT STENT VAMF4242150 WERE IMPLANTED WHICH APPEARED TO SEAL THE ENDOLEAK. BUT THE PATIENT THEN WENT INTO CARDIAC ARREST, CPR WAS COMMENCED BUT THE PATIENT COULD NOT BE REVIVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNKNOWN. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE SUFFERED A MYOCARDIAL INFRACTION DURING THE PROCEDURE. THE CAUSE OF DEATH WAS ALSO STATED TO BE RELATED TO THE TYPE III ENDOLEAK RUPTAND URE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Myocardial Infarction; Pain; Rupture

  MAUDE report 12201787 ↗
• InjurySep 23, 2020Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 83MM IN DIAMETER THORACOABDOMINAL AORTIC ANEURYSM (TAAA). A FURTHER 3 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED SEVEN MONTHS LATER. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 3.5 YEARS POST INDEX PROCEDURE WITH CHEST AND BACK PAIN. A CT PERFORMED SHOWED A POSSIBLE IIIB ENDOLEAK IN THE PROXIMAL COMPONENT AND THE DISTAL STENT GRAFT HAD MINIMAL OVERLAP WITH PARTIAL SEPARATION. IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED PROXIMALLY AND DISTALLY. IT WAS THOUGHT THE IIIB ENDOLEAK APPEARED TO BE AT THE JUNCTION OF A NON MDT (GORE) STENT GRAFT AND AN UNKNOWN VALIANT CAPTIVIA STENT GRAFT. THE DISTAL SEPARATION ENDOLEAK WAS BETWEEN 2 VALIANT CAPTIVIA STENT GRAFTS (EXACT DEVICES UNKNOWN). INTERVENTION WAS PERFORMED ON THE SAME DATE, A VNMC4646C175TU WAS IMPLANTED IN THE DISTAL SEGMENT OF THE GRAFT TO COVER THE SEPARATION. A VNMF4646C182TU STENT GRAFT WAS IMPLANTED TO COVER PROXIMAL OVERLAP AND POSSIBLE GRAFT HOLE. THIS RESOLVED THE ENDOLEAKS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 10572384 ↗
• MalfunctionDec 14, 2018Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT AS PART OF A CLINICAL TRIAL FOR THE VALIANT MONO LSA STENT GRAFT SYSTEM ON FOR THE ENDOVASCULAR TREATMENT OF A 55MM FUSIFORM ANEURYSM. IT WAS REPORTED THAT AN UNDETERMINED ENDOLEAK WAS OBSERVED ON THE PATIENTS DISCHARGE CT APPROXIMATELY ONE MONTH POST THE INDEX PROCEDURE, ON THE 2-MONTH FOLLOW UP CT AND AGAIN ON THE 12-MONTH FOLLOW UP CT. THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163699 ↗
• MalfunctionSep 3, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY THREE YEARS LATER, THE PATIENT RETURNED FOR FOLLOW UP AND A CT SCAN IDENTIFIED A TYPE IA ENDOLEAK. THE PHYSICIAN SCHEDULED THE PATIENT FOR A PROXIMAL EXTENSION ENDOGRAFT TO SATISFY THE NECK GROWTH AND SEAL THE ENDOLEAK. IT WAS REPORTED THE PATIENTS¿ TORTUROUS ANATOMY IN THE DESCENDING THORACIC AORTA WOULD NOT ALLOW THE EXTENSION TO BE ADVANCED INTO THE PROPER POSITION FOR DEPLOYMENT. THE EFFORT WAS ABANDONED AND FEMORAL CUT-DOWNS REPAIRED WITHOUT PATIENT INJURY. THE ISSUE HAS NOT BEEN RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO THE PATIENTS¿ TORTUROUS ANATOMY AND DISEASE PR OGRESSION. ITWAS REPORTED DISEASE PROGRESSION CONTRIBUTED TO A PROXIMAL NECK DILATION OF THE THORACIC AORTA BEYOND THE DIMENSIONS OF THE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840767 ↗
• MalfunctionJul 3, 2018Difficult to Insert; Difficult To Position; Device Damaged by Another Device; Difficult to Insert; Difficult To Position; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO IMPLANT A VALIANT STENT GRAFT IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM FUSIFORM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THERE WERE TWO DOUBLE BACK CURVES IN THE AORTA AND THE GOTHIC ARCH. EXTREME VESSEL TORTUOSITY WAS NOTED IN THE THORACIC AORTA. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE A 24FR SENTRANT SHEATH WAS PLACED IN THE FEMORAL ARTERY TO ASSIST WITH DELIVERY OF ALL PLANNED STENT GRAFTS. THE 24FR SIZE WAS CHOSEN AS THE SIZE OF THE PRIMARY STENT GRAFT (VALIANT 40X40X200). IT WAS REPORTED THAT, DUE TO THE EXTREME TOURISTY OF THE ANATOMY THE PHYSICIAN INITIALLY ELECTED TO USE ANOTHER MANUFACTURER THORACIC STENT GRAFT TO TRY TO STRAIGHTEN OUT THE AORTA IN ORDER TO PASS THE VALIANT DEVICES. IT WAS REPORTED THAT THE PHYSICIAN WENT IN AND OUT OF THE SENTRANT SHEATH SEVERAL TIMES AND FOUND THE 24FR SENTRANT WAS VERY TIGHT. IT WAS REPORTED IT REQUIRED A LOT OF STRENGTH TO GET THE NON-MDR STENT GRAFT UP AND THAT THE NON-MDT STENT GRAFT COULD NOT BE DEPLOYED. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE VALIANT DELIVERY SYSTEM BUT AGAIN IT WAS REPORTED AS EXTREMELY DIFFICULT TO PASS THE VALIANT DELIVERY SYSTEM THROUGH THE SENTRANT SHEATH. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657858 ↗
• DeathNov 3, 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 ENDOVASCULAR TREATMENT OF AN 80MM THORACIC AORTIC ANEURYSM. THE PATIENT APPEARED TO BE FINE POST PROCEDURE WITH BLOOD PRESSURE, HEART RATE AND HAEMOGLOBIN IN ORDER; HOWEVER, IT WAS REPORTED THAT THE NEXT DAY, WHILE IN ICU, THE PATIENT SUDDENLY DIED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT, WAS MOST LIKELY RELATED TO A MASSIVE CARDIAC EVENT. THE PHYSICIAN FURTHER STATED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE STENT GRAFT OR THE PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN WAS TOLD BY THE PATIENT THAT SHE HAD 2 THORACIC DEVICES IMPLANTED DURING A PREVIOUS TEVAR PROCEDURE PERFORMED ON AN UNKNOWN DATE IN ANOTHER HOSPITAL. UPON REVIEW OF THE CT IMAGES A TYPE IA AND A TYPE IB ENDOLEAK WAS NOTED FROM A DEVICE WHICH APPEARED TO BE A MEDTRONIC TALENT STENT GRAFT ALTHOUGH THIS CANNOT BE CONCLUSIVELY CONFIRMED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6998578 ↗
• MalfunctionOct 16, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 80 MM IN DIAMETER THORACIC AORTIC ANEURYSM ON THE. IT WAS REPORTED THAT ON CT IMAGING THE PHYSICIAN OBSERVED A DISTAL ENDOLEAK. THE PHYSICIAN BELIEVES THAT THIS MAY BE EITHER A TYPE II OR TYPE IB ENDOLEAK. THE PHYSICIAN PLANS TO RE-SCAN IN ONE MONTH AND DETERMINE A COURSE OF ACTION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951469 ↗
• MalfunctionMay 18, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PENETRATING AORTIC ULCER. IT WAS REPORTED THAT A FOLLOW-UP CT SHOWED A PROXIMAL TYPE I ENDOLEAK AND THE PAU HAS GROWN TO 6.2CM. THE PATIENT HAS A BOVINE ARCH AND THE ORIGINAL GRAFT COVERED THE SUBCLAVIAN. A CAROTID SUBCLAVIAN BYPASS WAS DONE AT THE ORIGINAL PROCEDURE. THE SUBCLAVIAN WAS COILED. THERE WAS 18MM FROM THE BRACHIOCEPHALIC TO THE PROXIMAL EDGE OF THE 36X36X200. THE DECISION WAS MADE TO PLACE A VALIANT CAPTIVIA TO SEAL THE TYPE I ENDOLEAK. THE GRAFT WAS PLACED AT THE INTENDED LOCATION AND A RELIANT BALLOON WAS USED. THE TYPE I ENDOLEAK WAS STILL FILLING AT THE END OF THE PROCEDURE. THE PHYSICIAN BALLOONED MULTIPLE TIMES WITH NO SUCCESS. IT WAS NOTED THAT THE PATIENT WAS ABLE TO MOVE THEIR EXTREMITIES AT THE END OF THE PROCEDURE. THE PATIENT WAS STABLE AND OTHERWISE SYMPTOM FREE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION VS GRAFT NOT OPPOSING WALL DUE TO BARE STENTS ON PREVIOUS PLACED GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6576140 ↗
• InjuryMar 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. THE PROXIMAL LANDING ZONE, JUST DISTAL TO THE LEFT COMMON CAROTID ARTERY MEASURED BETWEEN 37 MM AND 38 MM IN DIAMETER. THE PATIENT HAD AN ENLARGED, GREATER THAN 4 CM, ASCENDING AORTA AND IT WAS NOTED THAT THIS WAS A RISK FACTOR FOR RETROGRADE TYPE A AORTIC DISSECTIONS. POST INDEX PROCEDURE, THE PATIENT HAD MILD NEUROLOGIC DEFICIT AND COPS PROTOCOL WAS INITIATED. SEVERAL HOURS POST-PROCEDURE, THE PATIENT COMPLAINED OF NEW ONSET CHEST PAIN AND HEADACHE WITH DROP IN SYSTOLIC BLOOD PRESSURE TO 80¿S. BEDSIDE TTE SHOWED A LARGE PERICARDIAL EFFUSION. DUE TO SUSPECTED ACUTE TYPE A AORTIC DISSECTION, THE PATIENT WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR CONFIRMATION OF THE DIAGNOSIS BY TEE AND SURGICAL INTERVENTION. ON ARRIVAL TO THE OPERATING ROOM, THE PATIENT WAS SEVERELY HYPOTENSIVE. HE WAS PLACED IN THE SUPINE POSITION AND ADMINISTERED A GENERAL ENDOTRACHEAL ANESTHESIA. TEE CONFIRMED THE PRESENCE OF A LARGE PERICARDIAL EFFUSION WITH A TYPE A AORTIC DISSECTION. THE PERICARDIUM WAS PARTIALLY OPENED AT THE DIAPHRAGMATIC ASPECT. LARGE AMOUNT OF BRIGHT RED BLOOD (~ 600 ML) WITH CLOTS WERE EVACUATED WITH AN IMMEDIATE INCREASE OF BLOOD PRESSURE FROM ~ 50/

  Patient problems: Low Blood Pressure/ Hypotension; Pain; Pericardial Effusion; Vascular Dissection

  MAUDE report 6415372 ↗
• InjuryJan 26, 2017Difficult To Position; Difficult to Remove; Difficult To Position; Difficult to Remove

  A VALIANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER THORACIC AORTIC ANEURYSM. T HERE WAS SEVERE THROMBUS IN THE DESCENDING AORTA AND THE EXTERNAL ILIAC ARTERIES WERE TORTUOUS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN WAS UNABLE TO DELIVER THE DEVICE THROUGH THE 6MM ILIAC ARTERY. THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE SO, A RETROPERITONEAL INCISION WAS PERFORMED TO EXPOSE THE COMMON AND EXTERNAL ILIAC ARTERY. AN 8MM CONDUIT WAS SEWN PROXIMALLY AND THE DEVICE WAS REMOVED WITH APPROXIMATELY 3-4CM OF THE INTIMA LAYER ON THE GRAFT COVER. A NEW DEVICE WAS OPENED AND SUCCESSFULLY ADVANCED THROUGH THE 8MM CONDUIT RESOLVING THE EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ATTEMPTING TO ADVANCE A 24FR VALIANT SHEATH (8MM) INTO A 6MM EXTERNAL ILIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6281691 ↗