Sentrant™ SENSH1628W (UDI 00643169792593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169792593), received between Jun 30, 2021 and Jun 22, 2023 — classified as 4 deaths, 2 injuries, 1 malfunction.

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

• DeathJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENTRANT SHEATHS WERE USED AS ACCESSORY DEVICES IN THE IMPLANT OF A MEDTRONIC EVOLOUT HEART VALVE.  IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTED THE PATIENT HAD SEVERE PERIPHERIC ARTERIAL DISEASE, WITH NO CONDITIONS FOR TRANSFEMORAL ACCESS.   AXILLARY AND SUBCLAVIAN ACCESS WERE ANALYZED, WHICH HAD ADEQUATE CALIBER, BUT THE ARTERY ALSO WITH ATHEROSCLEROTIC DISEASE. AXILLARY ARTERY PUNCTURE WAS PERFORMED IN AN ATTEMPT TO INSERT THE SENTRANT AND DELIVERY SHEATH, AND A AXILLARY ARTERY LACERATION WAS OBSERVED. IN AN ATTEMPT TO RECANALIZE AND IMPLANT A COVERED STENT, THE PATIENT EVOLVED WITH HEMORRHAGIC SHOCK, CARDIAC ARREST AND DEATH. THE PATIENT DID NOT RESPOND TO CARDIOPULMONARY RESUSCITATION MANEUVERS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Perforation of Vessels

  MAUDE report 17181848 ↗
• MalfunctionJul 19, 2022Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  A SENTRANT SHEATH WAS INTENDED TO BE USED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED DURING THE INDEX PROCEDURE THE DEVICE WAS PREPPED ACCORDINGLY AND INSERTED OVER THE WIRE. ONCE THE DILATOR WAS REMOVED , THE VALVE BEGAN LEAKING AROUND WIRE. THE PHYSICIAN ATTEMPTED TO ADJUST THE WIRE AND INSERTED A CATHETER OVER THE WIRE TO TRY TO STOP THE LEAK. THE SHEATH WAS EXCHANGED FOR A NEW ONE IN ORDER TO COMPLETE THE CASE AND THE NEW SHEATH HAD NO VALVE ISSUE AND THE P ROCEDURE WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO A MANUFACTURING ERROR. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052139 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT INTRODUCER SHEATH WAS ATTEMPTED TO BE USED AS AN ACCESSORY DEVICE FOR A UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE SHEATH WAS REMOVED FROM THE RIGHT COMMON FEMORAL ARTERY ACCESS AND THE SUTURES WERE CINCHED DOWN. IT WAS STATED THAT SIGNIFICANT BLEEDING WAS STILL PRESENT AND THE THIRD PROGLIDE DEVICE WAS ATTEMPTED TO PREVENT THE BLEEDING FROM RESULTING IN A CUT DOWN. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ACHIEVE ADEQUATE HEMOSTASIS AND THUS A SURGICAL CUTDOWN WAS PERFORMED WITH PRIMARY REPAIR OF THE VESSEL AND MULTIPLE LAYERS OF RUNNING SUTURES. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE SHEATH, NOT RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE TRANSCATHETER AORTIC VALVE. SPONSOR ASSESSED THE EVENT AS RELATED TO THE SHEATH, RELATED TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE TRANSCATHETER AORTIC VALVE. AS PER THE PHYSICIAN THE CAUSE WAS LIKELY THE RECENT USE OF ANGIOSEAL FOR DIAGNOSTIC CATH AT OUTSIDE HOSPITAL WHICH DID NOT ALLOW FOR PERCLOSE SUTURES TO SEAL. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12391681 ↗
• DeathAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS ATTEMPTED TO BE USED AS AN ACCESSORY DEVICE OF FOR A UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN ATTEMPTED TO USE A 14 FR SENTRANT SHEATH TO DILATE THE ARTERY, BUT DIFFICULTIES TO RAISE THE SYSTEM WITH THE PROSTHESIS WAS ENCOUNTERED. THE PHYSICIAN THEN ATTEMPTED TO USE A 16 FR SENTRANT SHEATH TO DILATE THE ARTERY AND THE SYSTEM STILL DID NOT RISE. IT WAS REPORTED THAT THE PATIENT BEGAN TO BLEED, SUFFERED SIX CARDIAC ARRESTS. ADRENALINE WAS THEN ADMINISTERED. A DISSECTION IN THE ILIAC-FEMORAL ARTERIES WAS NOTED, WHERE IT WAS TREATED WITH A VASCULAR SURGEON INTERVENTION AND 2 NON-MEDTRONIC STENTS WERE IMPLANTED. PATIENT STILL IN ICU. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO THE PRESENCE OF CIRCULAR CALCIUM IN THE ILIAC-FEMORAL ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Perforation of Vessels

  MAUDE report 12359748 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM ABDOMINAL AORTIC ANEURYSM. A SENTRANT SHEATH WAS ALSO USED. THE PROCEDURE WAS ALSO FOCUSED ON THE REVISION OF A PREVIOUSLY IMPLANTED NON MDT (AFX) STENT GRAFT SYSTEM. IT WAS REPORTED THAT PERCUTANEOUS ACCESS WAS ATTEMPTED BUT DUE TO SCAR TISSUE FROM THE FIRST PROCEDURE ACCESS WAS DIFFICULT, THE PROCEDURE THEN WAS CONVERTED TO OPEN REPAIR. IT WAS SAID IT WAS CHALLENGING TO PLACE WIRES WITHOUT ENTANGLEMENT INSIDE THE NON MDT STENT GRAFT SYSTEM. IT WAS REPORTED IMPLANTING THE ENDURANT IIS STENT GRAFT SYSTEM WAS UNEVENTFUL AND WELL PLACED. THE PROCEDURE RAN FOR 3.5 HOURS. THE NEXT DAY, UNIDENTIFIABLE POST-OPERATIVE BLEEDING OCCURRED. THE PATIENT REQUIRED AN OPEN EXPLORATORY SURGERY AND ALSO VACUUM-ASSISTED CLOSURE (VAC) OF THE WOUND WAS NEEDED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PHYSICIAN DIDN'T SUSPECT THE SENTRANT OR ENDURANT DEVICES PLAYED A ROLE IN CAUSING THE BLEEDING. HOWEVER IT WAS CONSIDERED THAT THE DEVICES MAY HAVE HELPED TO HIDE THE BLEEDING.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12337577 ↗
• DeathAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM ABDOMINAL AORTIC ANEURYSM. IT WAS DECIDED PRE-OPERATIVELY THE APPROACH VIA THE PATIENTS LEFT FEMORAL ARTERY WOULD BE MOST BENEFICIAL DUE TO THE ANGULATION OF AORTIC NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE PHYSICIAN PERFORMED CUTDOWNS TO THE LEFT AND RIGHT COMMON FEMORAL ARTERIES. USING A THIN-WALLED NEEDLE, ACCESS WAS MADE TO THE RIGHT FEMORAL ARTERY AND A .035" (NON MEDTRONIC) WIRE WAS ADVANCED UNDER FLUOROSCOPY. THE THIN-WALLED NEEDLE WAS REMOVED OVER THE WIRE. A HEMOSTATIC SHEATH WAS INSERTED INTO THE VESSEL OVER THE WIRE. A MARKER FLUSH CATHETER WAS ADVANCE OVER THE .035" WIRE TO THE LEVEL OF L1, AND THE WIRE WAS REMOVED. THE MARKER FLUSH CATHETER WAS CONNECTED TO A POWER INJECTOR WITH A WET TO WET CONNECTION. THE PHYSICIAN THEN GAINED ACCESS TO THE LEFT FEMORAL ARTERY USING A THIN-WALLED NEEDLE AND ADVANCED A .035" WIRE UNDER FLUOROSCOPY. THE THIN-WALLED NEEDLE WAS REMOVED OVER THE WIRE, AND A HEMOSTATIC SHEATH WAS INSERTED INTO THE LEFT FEMORAL ARTERY OVER THE WIRE. A DIRECTIONAL CATHETER WAS BACK-LOADED ONTO THE .035"WIRE. THE .035" WIRE WAS ADVANCED FOLLOWED BY T

  Patient problems: Cardiac Arrest

  MAUDE report 12330370 ↗
• DeathJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED IN A PROCEDURE WHERE A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED IN A PATIENT WITH SEVERE AORTIC STENOSIS. A STENT WAS ALSO PLACED TO PROTECT THE LEFT CORONARY ARTERY TRUNK. AT THE END OF THE IMPLANT PROCEDURE, THE CORONARY ARTERIES SHOWED LAMINAR FLOW. THIRTY MINUTES FOLLOWING VALVE IMPLANT, THE PATIENT REPORTED SEVERE CHEST PAIN. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, BUT THE PATIENT REMAINED IN A STATE OF SHOCK. AN AORTOGRAPHY WAS PERFORMED AND SHOWED TOTAL OCCLUSION OF BOTH CORONARY ARTERIES. CARDIOPULMONARY RESUSCITATION WAS INITIATED, BUT UNSUCCESSFUL AND THE PATIENT DIED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Pain; Pericardial Effusion

  MAUDE report 12091469 ↗