Sentrant™ SENSH2028W (UDI 00643169792616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169792616), received between Jun 4, 2019 and Nov 15, 2023 — classified as 3 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathNov 15, 2023Difficult to Remove; Difficult to Remove

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING THE TREATMENT OF A DISSECTION FLAP THAT EXTENDED FROM BOTH ILIACS TO THE LSA. THE PATIENT HAD INITIALLY UNDERGONE A PCI RESULTING IN A DISSECTED RCA, FOLLOWED BY CABG WITH AN AV VALVE. WHILE ON ECMO, THE PATIENT HAD A COLD, PALE, AND PARALYZED FOOT. PRIOR TO THE PLACEMENT OF A THORACIC STENT TO ADDRESS THE DISSECTION FLAP EXTENDING FROM BOTH ILIACS TO THE LSA, THE PATIENTS LEG WAS AMPUTATED. IT WAS REPORTED DURING THE PROCEDURE TO IMPLANT THE STENT IN THE DESCENDING AORTA THE SENTRANT SHEATH WAS IN THE RIGHT COMMON ILIAC. AFTER THE STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED THE PHYSICIAN WAS UNABLE TO MOVE THE SHEATH PROXIMAL OR DISTAL. NI TROGLYCERIN WAS GIVEN. THE SHEATH WAS REMOVED WITH THE BLOOD PRESSURE RAPIDLY DECREASING. A RUPTURE OF THE RIGHT COMMON ILIAC OCCURRED AFTER THE SHEATH WAS REMOVED. SEVERAL COVERED STENTS WERE PLACED TO COVER THE RUPTURE BUT A LEAK STILL REMAINED. COMPRESSIONS WERE GIVEN AND THE PATIENT WAS SENT TO THE FLOOR. IT WAS REPORTED THE PATIENT LATER EXPIRED. THE CAUSE OF THE RUPTURE WAS DETERMINED TO BE ANATOMY RELATED WHERE IT WAS NOTED THAT THE ARTERY WAS FRAGILE LEADING TO THE RUPTURE. THE CA

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 18139459 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE TREATMENT OF A 155MM TYPE B AORTIC DISSECTION.  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, FEMORAL ACCESS WAS GAINED BILATERALLY. WIRES WERE PLACED PROPERLY FOLLOWED BY A PIGTAIL MARKER ON THE RIGHT SIDE AND IVUS ON THE LEFT SIDE. THE IVUS USED SHOWED THE LOCATION WAS  IN THE TRUE LUMEN. TRUE LUMEN VERIFICATION WAS ESTABLISHED BASED OFF THE KNOWN VISCERAL VESSELS COMING OFF TRUE LUMEN AND THE AORTIC ARCH VESSELS. MEASUREMENTS WERE TAKEN USING IVUS FOR CONFIRMATION ALONG WITH THE CT SCAN FOR PROPER GRAFT SELECTION . ONCE THE TRUE LUMEN WAS ESTABLISHED A STIFF WIRE WAS ADVANCED INTO THE AORTA PROPERLY AND PROPERLY SEATED AROUND THE ARCH. ONCE THE GUIDEWIRE WAS ESTABLISHED, AN IVUS WAS USED TO MONITOR ALL THE WAY DOWN UNTIL IT EXITED THE PATIENT.  AN AORTOGRAM WITH THE PIG TAIL WAS THEN USED TO NOTE A FOCAL FENESTRATION CAUSING THE DISSECTION. THE 42X42X200 VALIANT CAPTIVIA AORTIC GRAFT WAS THEN PLACED ON THE LEFT WIRE AND  ADVANCED THROUGH THE LEFT FEMORAL ACCESS. ACCESS WAS TIGHT THEREFORE THE DEVICE WAS PULLED OUT AND THE ACCESS WAS PREDILATED WITH A  20FR SHEATH. THE SHEATH WAS REMOVED AND THE VALIANT CAPTIVIA WAS ADVANCED

  Patient problems: Perforation of Vessels

  MAUDE report 17955909 ↗
• DeathMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SENTRANT SHEATHS WERE USED AS A CONDUIT DURING A MEDTRONIC VALVE IMPLANT . IT WAS REPORTED DURING THE INDEX PROCEDURE THAT THE PATIENT HAD MULTIPLE COMPLICATIONS DURING THE PROCEDURE. WHEN THE DELIVERY SYSTEM WAS REMOVED, RIGHT FEMORAL OCCLUSION WAS OBSERVED. AFTER CLOSURE WITH PERCOLES, WITHOUT LACERATIONS OR BLEEDING, A COVERED STENT WAS IMPLANTED WITH EXCELLENT RESULTS. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT IN THE ICU, AFTER 2 HOURS AFTER LEAVING THE ROOM WITH, THE PATIENT DEVELOPED HYPOTENSION AND WAS DIAGNOSED WITH CARDIAC TAMPONADE. AN URGENT PERICARDIOCENTESIS WAS PERFORMED, AND ANOTHER BLEED WAS IDENTIFIED IN THE PUNCTURE ATTEMPT. THE PATIENT WAS REFERRED TO THE OPERATING ROOM, WHERE A STERNOTOMY AND EXPLORATORY LAPAROTOMY WERE PERFORMED. MULTIPLE LACERATIONS WERE IDENTIFIED IN THE LIVER AS THE CAUSE OF THE BLEEDING. ON THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT PROGRESSED TO DEATH. PER PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO HEMORRHAGIC SHOCK. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Liver Laceration(s); Low Blood Pressure/ Hypotension; Obstruction/Occlusion

  MAUDE report 13706645 ↗
• DeathMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE WITH A THORACIC VISCERAL MANIFOLD STENT GRAFT THAT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM AORTIC ANEURYSM. A NON MDT 38MM X 150 DEVICE WAS UTILIZED TO RELIGN THE EXISTING GRAFT PER PROTOCOL. THE NON MDT DEVICE WAS DEPLOYED WITH NO ISSUE. BALLOONING WAS PERFORMED WITH A NON MDT BALLOON POST IMPLANT. FOLLOWING TEVAR, A 40MM THORACIC BIFURCATE WAS UTILIZED WITHIN THE NON MDT DEVICE AND FOLLOWED BY A VISCERAL MANIFOLD. BALLOONING OF THE MENTIONED DEVICES AND SMA, AND BOTH RENAL ARTERIES WERE SELECTED OUT AND BYPASSED VIA NON MDT STENTS TO THE MANIFOLD LIMBS. ALL WENT WITH NO ISSUE. LATER THAT EVENING, THE PHYSICIAN NOTED THAT THE PATIENT HAD NO PULSE IN THE LEFT LEG AS THEREFORE THE PHYSICIAN HAD TO STENT THE LEFT ILIAC DUE TO DISSECTION. THE PHYSICIAN SAID THE PROBABLE CAUSE WAS THE SHEATH BEING USED. ALL WAS WELL AFTER THE STENTING OF THE LEFT ILIAC WAS PERFORMED. IT WAS NOTED THAT THE PATIENT WASN'T MOVING THEIR LEGS. THEY BEGAN DRAINING THE PATIENTS SPINAL DRAIN AND INCREASING PRESSURE. THE VISCERAL MANIFOLD WAS OCCLUDED. IT WAS REPORTED THE NEXT DAY THAT THE PATIENT HAD EXPIRED. AS PER THE PHYSICIAN THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Paralysis; Vascular Dissection

  MAUDE report 11562713 ↗
• MalfunctionOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A SENTRANT SHEATH WAS USED AS A CONDUIT FOR AN UNKNOWN DEVICE DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE THE VALVE ON THE SENTRANT SHEATH BECAME LOOSE AND NEEDED TO BE POPPED BACK INTO PLACE. THE VALVE WAS POPPED BACK INTO PLACE AND THE CASE CONTINUED WITH NO IMPACT TO THE PATIENT REPORTED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS SUSPECTED TO BE FAULT WITH THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9165548 ↗
• InjuryJun 4, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS INTENDED FOR IMPLANT IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 14 MM THORACIC AORTIC PAU. THE DIAMETER OF THE AORTA AT THE PAU WAS 42 MM. THE PATIENT HAD A PREVIOUS EVAR WITH AN ENDURANT DEVICE ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN FIRST TRIED TO GAIN ACCESS VIA THE RIGHT SIDE, BUT IT WAS OCCLUDED. THEY THEN ACCESSED THE LEFT COMMON FEMORAL, WHICH WAS NARROW. THE PHYSICIAN USED A NON-MEDTRONIC PTA 7 X 60 MM NON-COMPLIANT BALLOON. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE VALIANT CAPTIVIA PERCUTANEOUSLY VIA THE ACCESS VESSEL, BUT IT DID NOT ADVANCE. THE PHYSICIAN THEN IMPLANTED TWO 8 X 59 MM NON-MEDTRONIC AND ONE 8 X 39 MM, AND ADVANCED AN 18 FR NON-MEDTRONIC DILATOR THROUGH THE STENTS. AN ATTEMPT WAS THEN MADE TO ADVANCE A 20 FR SENTRANT DILATOR THROUGH THE DISTAL NON-MEDTRONIC STENT, BUT IT DID NOT ADVANCE. THE PHYSICIAN THEN INFLATED A 9 MM NON-MEDTRONIC BALLOON IN THE 3 STENTS. THEY THEN ATTEMPTED TO ADVANCE THE 18 FR NON-MEDTRONIC SHEATH, BUT IT DID NOT ADVANCE. AN ANGIOGRAM WAS THEN PERFORMED, AND IT WAS OBSERVED THAT THE DISTAL LEIA WAS RUPTURED AND THERE WAS EXTRAVASATION OUTSIDE

  Patient problems: Paralysis; Perforation of Vessels; Stroke/CVA

  MAUDE report 8666600 ↗