Sentinel CMS15-10C-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00863229000004), received between Jun 22, 2018 and Sep 15, 2026 — classified as 2 deaths, 33 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (94 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Nonstandard Device; Failure to Unfold or Unwrap; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779704 ↗
• InjurySep 11, 2026Mechanical Jam

  It was reported that the patient experienced a cerebral vascular accident.A Sentinel cerebral protection system (CPS) was utilized for embolic protection during a transcatheter aortic valve replacement (TAVR) procedure. One day post-procedure, the patient experienced a cerebral vascular accident. The patient is hospitalized and receiving medication and other management. The patients symptoms are improving. The physician assessed the event as related to the Sentinel CPS procedure and the TAVR procedure.

  Patient problems: Stroke/CVA

  MAUDE report 50736515 ↗
• InjuryAug 19, 2026Failure to Advance

  It was reported via poster presentation that difficulty/failure to place device and stroke occurred. This presentation discussed evaluation of cases with difficulty deploying the Sentinel during transfemoral transcatheter aortic valve implant procedures. A total of 102 cases in which the Sentinel was used between (b)(6) 2025 and (b)(6) 2026 were analyzed to examine the anatomical characteristics and other factors in cases where placement was difficult. There were 12 cases of placement difficulty; in 5 of these, the entire device had to be removed due to the difficulty, while in 7 cases, only the proximal filter was partially placed because the distal filter could not be placed. Analysis of preoperative CT scans revealed that cases with placement difficulty involved tortuosity or calcification of the brachiocephalic artery. Cerebral infarction was observed in 2 cases within 30 days postoperatively; however, no other complications (such as vascular complications or major bleeding) were observed.

  Patient problems: Stroke/CVA

  MAUDE report 50333752 ↗
• MalfunctionJun 15, 2026Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT DEVICE BECAME STUCK WITHIN SHEATH. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS SELECTED FOR USE IN A PROCEDURE. A NON-BOSTON SCIENTIFIC 5/6FR INTRODUCER SHEATH WAS PLACED. DURING INSERTION OF THE SENTINEL CPS INTO THE NON-BSC INTRODUCER SHEATH, THE SENTINEL CPS BECAME STUCK AND THE NON-BSC INTRODUCER SHEATH AND SENTINEL CPS REQUIRED REMOVAL TOGETHER AS A UNIT. A NEW SHEATH WAS PLACED, AND A NEW SENTINEL CPS WAS UTILIZED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511037 ↗
• MalfunctionJun 15, 2026Nonstandard Device; Failure to Unfold or Unwrap; Material Integrity Problem

  IT WAS REPORTED THAT FILTER MATERIAL TEAR OCCURRED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS BEING PERFORMED WITH A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE SENTINEL CPS WAS ADVANCED TO THE INTENDED LOCATION. DURING DEPLOYMENT OF THE PROXIMAL FILTER, THE PHYSICIAN OBSERVED RESISTANCE. AFTER SEVERAL DEPLOYMENT ATTEMPTS, THE SENTINEL WAS REMOVED FROM THE PATIENT AND ANALYZED OUTSIDE THE BODY. THE PROXIMAL FILTER HAD BECOME STUCK INSIDE THE CATHETER, AND THE FILTER MATERIAL HAD TORN. A NEW SENTINEL CPS WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25508429 ↗
• MalfunctionJun 3, 2026Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT FAILURE TO RECAPTURE FILTER OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS BEING PERFORMED WITH A SENTINEL CEREBRAL EMBOLIC PROTECTION (CPS) FOR EMBOLIC PROTECTION. AFTER THE TAVR PROCEDURE, DURING RETRIEVAL OF THE SENTINEL CPS, THE PROXIMAL FILTER FAILED TO RE-SHEATH DESPITE ATTEMPTS. THE PHYSICIAN HAD TO REMOVE THE CPS DEVICE IN MULTIPLE PIECES BY CUTTING AND SNARING FROM THE GROIN. NO PATIENT ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376726 ↗
• MalfunctionMay 19, 2026Nonstandard Device; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT PARTIAL FILTER DETACHMENT OCCURRED. A PROCEDURE WAS BEING PERFORMED WITH USE OF A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS). DURING THE PROCEDURE, THERE WAS DIFFICULTY DEPLOYING THE PROXIMAL FILTER AND DIFFICULTY OPERATING THE PROXIMAL FILTER SLIDER #1. THE PROXIMAL FILTER WAS RECAPTURED AND REPOSITIONED. IT WAS NOTED THAT THE PROXIMAL FILTER WAS PARTIALLY DETACHED FROM THE FILTER HOOP. THE PHYSICIAN NOTED THAT THE DIFFICULTY DEPLOYING THE DEVICE MAY HAVE BEEN RELATED TO THE CATHETER BEING MOVED TOGETHER WITH THE DEVICE AFTER DEPLOYMENT OF THE PROXIMAL FILTER. A NEW SENTINEL WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222680 ↗
• MalfunctionApr 29, 2026Difficult to Remove

  IT WAS REPORTED THAT FAILURE TO RECAPTURE FILTER OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS BEING PERFORMED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS SELECTED FOR EMBOLIC PROTECTION. THE SENTINEL CPS WAS ADVANCED TO THE INTENDED LOCATION. THE DISTAL FILTER WAS DEPLOYED, HOWEVER UPON ATTEMPT TO RE-SHEATH AND RE-POSITION, THE DISTAL FILTER FAILED TO RE-SHEATH DESPITE ATTEMPTS TO ADVANCE AND RETRACT THE DISTAL FILTER SLIDER #3. THE DEVICE WAS REMOVED SAFELY WITH THE DISTAL FILTER IN AN OPEN STATE. NO ADDITIONAL INTERVENTION WAS REQUIRED FOR REMOVAL AND NO PATIENT COMPLICATION OCCURRED. THE TAVR PROCEDURE WAS COMPLETED WITHOUT CEREBRAL EMBOLIC PROTECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037030 ↗
• MalfunctionMar 10, 2026Nonstandard Device; Difficult to Remove; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT FAILURE TO REMOVE DEVICE OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS USED DURING A PROCEDURE. A NON-BOSTON SCIENTIFIC RADIAL INTRODUCER SHEATH WAS USED. AT THE END OF THE PROCEDURE DURING WITHDRAWAL, THE SENTINEL CPS TIP GOT STUCK INSIDE THE NON-BSC RADIAL INTRODUCER SHEATH AND COULD NOT BE REMOVED. THE SENTINEL CPS WAS CUT AND THE ENTIRE NON-BSC RADIAL INTRODUCER SHEATH WAS REMOVED. NO ADVERSE EVENTS OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561523 ↗
• MalfunctionFeb 25, 2026Mechanical Problem; Nonstandard Device; Mechanical Jam

  IT WAS REPORTED THAT ARTICULATING SHEATH ISSUES OCCURRED. A SENTINEL WAS UTILIZED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE FOR EMBOLIC PROTECTION. IN AN ATTEMPT TO REMOVE THE DEVICE, THE ARTICULATING DISTAL SHEATH ENCOUNTERED AN ISSUE. WHEN ATTEMPTING TO TURN THE KNOB #2, THE ARTICULATING DISTAL SHEATH DID NOT CORRESPOND ACCORDINGLY. IT SEEMED THAT IT DID NOT TURN AT ALL. THE KNOB #2 DID NOT MOVE FREELY. THE ARTICULATING DISTAL SHEATH DID NOT ROTATE SO THE CATHETER COULD NOT BE STRAIGHTENED. ALL FILTERS WERE FULLY RETRACTED AT THE TIME OF REMOVAL AND THE DEVICE WAS REMOVED WITH NO ADDITIONAL INTERVENTION. THE TAVR PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE SENTINEL. THE DEVICE WAS RECEIVED FOR ANALYSIS AND THE PROXIMAL SHEATH WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444648 ↗
• MalfunctionFeb 25, 2026Nonstandard Device; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE DETACHMENT AND FAILURE TO RECAPTURE PROXIMAL FILTER OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS BEING PERFORMED WITH A SENTINEL CEREBRAL EMBOLIC PROTECTION (CPS) FOR EMBOLIC PROTECTION. AFTER THE TAVR PROCEDURE, DURING RETRIEVAL OF THE SENTINEL CPS, THE PROXIMAL FILTER ENCOUNTERED DIFFICULTY RECAPTURING. IT WAS NOTICED THAT THE PROXIMAL SHEATH RADIOPAQUE MARKER HAD DETACHED AND BECAME ENTANGLED WITH THE PROXIMAL FILTER, PREVENTING RECAPTURE OF THE PROXIMAL FILTER. NO ADDITIONAL INTERVENTION WAS REQUIRED, AND THE DEVICE WAS REMOVED FROM THE PATIENT ANATOMY WITH THE PROXIMAL FILTER IN THE OPEN, ENTANGLED STATE. NO PATIENT ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443886 ↗
• MalfunctionFeb 4, 2026Difficult to Remove

  IT WAS REPORTED THAT FILTER FAILED TO FULLY RECAPTURE. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED WITH A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. AT THE CLOSURE OF THE TAVR PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY RECAPTURING THE PROXIMAL FILTER OF THE SENTINEL CPS. THE REAR AND FRONT HANDLE OF THE SENTINEL CPS COULD NOT BE INTEGRATED DURING THE FILTER RETRIEVAL, MAKING IT IMPOSSIBLE TO FULLY RETRACT THE PROXIMAL FILTER. THE PROXIMAL FILTER WAS ABLE TO BE PARTIALLY RECAPTURED AND WAS REMOVED FROM THE PATIENT ANATOMY IN THIS STATE. NO ADVERSE EVENTS OCCURRED. THE PATIENT WAS NOTED TO HAVE TORTUOUS ANATOMY. THE PHYSICIAN COMMENTED THAT DUE TO THE TORTUOSITY AT THE ORIGIN OF THE BRACHIOCEPHALIC ARTERY, THE SENTINEL CPS HANDLES COULD NOT BE INTEGRATED; AND IT WAS CONSIDERED THAT INTEGRATION MAY HAVE BEEN POSSIBLE IF MANIPULATION HAD BEEN PERFORMED WITHIN A STRAIGHTER VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261267 ↗
• MalfunctionJan 12, 2026Difficult to Remove

  IT WAS REPORTED THAT FILTER FAILED TO RECAPTURE. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS BEING PERFORMED, AND A SENTINEL CEREBRAL EMBOLIC PROTECTION (CEP) DEVICE WAS SELECTED FOR USE. THE SENTINEL CEP WAS INSERTED, AND THE DISTAL FILTER WAS DEPLOYED, HOWEVER THE DISTAL FILTER COULD NOT BE RETRACTED, AND THE FILTER HOOP COULD NOT BE RETRACTED INTO THE SHEATH, SO IT WAS REMOVED ALONG WITH THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039190 ↗
• MalfunctionDec 11, 2025Nonstandard Device; Difficult to Remove; Mechanical Jam; Nonstandard Device; Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT FAILURE TO CAPTURE FILTER OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS BEING PERFORMED WITH A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE SENTINEL CPS WAS ADVANCED TO THE INTENDED LOCATION. THE DISTAL FILTER WAS DEPLOYED AND RECAPTURED THREE TIMES; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHEN DEPLOYING THE DISTAL FILTER AND THE USER EXPERIENCED RESISTANCE WITH THE DISTAL FILTER SLIDER (#3). DURING WITHDRAWAL OF THE SENTINEL CPS, THE PROXIMAL FILTER WAS FULLY RETRACTED, HOWEVER APPROXIMATELY 1CM OF THE DISTAL FILTER, NEAR THE DISTAL TIP, COULD NOT BE COMPLETELY RETRACTED. THE SENTINEL CPS WAS REMOVED IN THIS STATE WITH NO ISSUES. THE PHYSICIAN COMMENTED THAT THE DISTAL TIP WAS UNUSUAL, SUGGESTING A POSSIBLE DEFECT. THE PHYSICIAN ALSO COMMENTED THAT THE PATIENT'S ANATOMY CONTAINED MILD STENOSIS AT THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. A NEW SENTINEL CPS WAS UTILIZED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782371 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STROKE OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS UTILIZED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. ONE DAY POST-PROCEDURE, THE PATIENT EXPERIENCED A NON-SERIOUS ISCHEMIC STROKE IDENTIFIED VIA NEUROIMAGING. THE PATIENT RECOVERED SAME DAY. THE PHYSICIAN ASSESSED THE EVENT AS RELATED TO THE SENTINEL CPS PROCEDURE AND THE TAVR PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 23782025 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STROKE OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS UTILIZED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A NON-SEVERE ISCHEMIC STROKE IDENTIFIED VIA NEUROIMAGING. THE PATIENT RECOVERED SAME DAY. THE PHYSICIAN ASSESSED THE EVENT AS RELATED TO THE SENTINEL PROCEDURE AND THE TAVR PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 23780824 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STROKE OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS UTILIZED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. SIX DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A NON-SERIOUS ISCHEMIC STROKE IDENTIFIED VIA NEUROIMAGING. THE PATIENT RECOVERED SAME DAY. THE PHYSICIAN ASSESSED THE EVENT AS RELATED TO THE SENTINEL CPS PROCEDURE AND THE TAVR PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 23780818 ↗
• MalfunctionNov 18, 2025Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  REPORTABLE UPON ANALYSIS 11 NOV 2025. IT WAS REPORTED THAT DIFFICULTY INSERTING DEVICE OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS SELECTED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) PROCEDURE. WHILE ATTEMPTING TO INSERT THE DEVICE INTO THE SEVERELY TORTUOUS ANATOMY, DIFFICULTY WAS ENCOUNTERED. THE SENTINEL CPS WAS REMOVED WITHOUT ISSUE AND A NEW SENTINEL CPS WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS RECEIVED BACK FOR ANALYSIS WITH THE PROXIMAL FILTER WAS PARTIALLY DETACHED FROM THE LOOPING FORMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585493 ↗
• MalfunctionNov 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DEVICE FAILED TO CAPTURE/RETRIEVE. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS BEING PERFORMED WITH USE OF A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE SENTINEL CPS WAS PREPARED WITHOUT ISSUE, INSERTED AND ADVANCED TO THE INTENDED LOCATION. THE DISTAL FILTER WAS DEPLOYED AND, IN AN ATTEMPT TO RECAPTURE FOR REPOSITIONING, THE DISTAL FILTER WOULD NOT PULL BACK INTO THE SHEATH AND APPEARED STUCK. AFTER MULTIPLE ATTEMPTS TO RECAPTURE THE DISTAL FILTER, THE PHYSICIAN REMOVED THE SENTINEL CPS FROM THE PATIENT. A SECOND SENTINEL CPS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584564 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT STROKE OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WAS PERFORMED WITH A SENTINEL CEREBRAL PROTECTION SYSTEM FOR EMBOLIC PROTECTION. FOUR DAYS POST-PROCEDURE THE PATIENT EXPERIENCED A NON-SEVERE, ISCHEMIC STROKE WHICH WAS DIAGNOSED VIA NEUROIMAGING. THE PATIENT RECOVERED SAME DAY. THE PHYSICIAN CAUSALLY RELATED IT TO THE SENTINEL PROCEDURE AND TAVR PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 23583801 ↗
• MalfunctionNov 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROXIMAL FILTER FAILED TO RECAPTURE. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS UTILIZED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. AT THE CLOSE OF THE PROCEDURE, THE PROXIMAL FILTER WAS DIFFICULT TO RETRACT, AND THE PHYSICIAN WAS UNABLE TO FULLY RECAPTURE FOR REMOVAL. THE SENTINEL CPS WAS REMOVED FROM THE PATIENT ANATOMY WITH THE PROXIMAL FILTER IN A DEPLOYED STATE. THE SENTINEL CPS WAS ABLE TO BE REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465242 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXTENDED HOSPITALIZATION OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS PERFORMED WITH USE OF A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) FOR EMBOLIC PROTECTION. THE PATIENT WAS NOT DISCHARGED UNTIL 30 DAYS AFTER THE PROCEDURE. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22998864 ↗
• InjurySep 3, 2025Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WAS BEING PERFORMED, AND A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS UTILIZED FOR EMBOLIC PROTECTION. THE SENTINEL CPS WAS KINKED AND COULD NOT BE DELIVERED TO THE POSITION DUE TO THE TORTUOUS ANATOMY. DIFFICULTY WAS ENCOUNTERED DURING REMOVAL OF THE DEVICE FROM THE PATIENT ANATOMY. AFTER REMOVAL, THE SENTINEL CPS WAS EXCHANGED FOR ANOTHER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE FIRST SENTINEL CPS WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. UPON ANALYSIS, THE PROXIMAL FILTER, DISTAL FILTER, ARTICULATING DISTAL SHEATH (ADS) AND A PORTION OF THE INNER MEMBER WERE DETACHED AND NOT RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THE DETACHMENT WAS ATTRIBUTABLE TO THE TORTUOUS ANATOMY. FURTHER INFORMATION ON THE CAUSE OF THE DETACHMENT AND IF IT OCCURRED DURING THE PROCEDURE OR AFTER REMOVED FROM THE ANATOMY REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955057 ↗
• MalfunctionAug 19, 2025Positioning Failure; Difficult to Remove; Defective Device; Positioning Failure; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT FAILURE TO RECAPTURE DISTAL FILTER AND DEVICE BREAK OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS SELECTED FOR USE FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT ANATOMY CONTAINED SEVERE TORTUOSITY OF THE SUBCLAVIAN ARTERY AND BRACHIAL ARTERY. THE SENTINEL CPS WAS ADVANCED INSIDE THE PATIENT. THE DISTAL FILTER COULD NOT BE DEPLOYED. THE ARTICULATING DISTAL SHEATH WAS NOTED TO BE BROKEN, AND THE DISTAL FILTER COULD NOT BE SLID AT ALL. THE FILTERS WERE NOTED TO BE FULLY RETRACTED WHEN REMOVING, HOWEVER, IT WAS FURTHER REPORTED THAT THE DISTAL FILTER WAS UNABLE TO BE CAPTURED. ATTEMPTS TO GAIN CLARIFICATION ON HOW THE DISTAL FILTER WAS UNABLE TO RECAPTURE WHEN IT WAS ALSO REPORTED TO FAIL TO DEPLOY AND BE REMOVED WITH THE FILTERS FULLY RETRACTED, HOWEVER FURTHER CLARIFICATION WAS NOT RECEIVED, THEREFORE THIS EVENT WAS CONSERVATIVELY REPORTED. THE PHYSICIAN SUSPECTED A POSSIBLE CAUSE OF THE EVENT WAS THE PATIENT'S SEVERE TORTUOSITY OF THE SUBCLAVIAN ARTERY AND BRACHIAL ARTERY. THE TAVR PROCEDURE WAS COMPLETED WITH A NEW SENTINEL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841240 ↗
• MalfunctionAug 1, 2025Positioning Failure; Difficult to Remove; Material Integrity Problem; Positioning Problem; Positioning Failure; Difficult to Remove; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED THAT FAILURE TO RECAPTURE FILTERS OCCURRED. A SENTINEL CEREBRAL PROTECTION SYSTEM (CPS) WAS SELECTED FOR EMBOLIC PROTECTION DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE SENTINEL CPS WAS ADVANCED INTO THE ANATOMY. THE PROXIMAL AND DISTAL FILTERS WERE DEPLOYED BUT MOVED OUT OF POSITION DURING DEPLOYMENT. BOTH FILTERS WERE RECAPTURED TWO TIMES AND DURING THE THIRD ATTEMPT, THE PHYSICIAN WAS UNABLE TO FULLY RECAPTURE THE PROXIMAL AND DISTAL FILTERS AND UNABLE TO PULL THE FRONT AND REAR HANDLES TOGETHER. AFTER REMOVING THE SENTINEL CPS FROM THE ANATOMY, THE PHYSICIAN WAS UNABLE TO DEPLOY THE FILTERS EASILY. THE TAVR PROCEDURE WAS COMPLETED USING AN ALTERNATE CPS. NO PATIENT COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686345 ↗