MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C-US

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that a distal filter dislodgement and difficulty removing the device occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter of the sentinel cps was deployed in brachiocephalic artery and the distal filter was deployed in the left common carotid (lcc) artery.During removal of the balloon aortic valvuloplasty (bav) balloon, the distal filter became disengaged from the lcc.Distal filter repositioning was reattempted, however, the articulating distal sheath (ads) kinked, and the distal filter was not able to redeploy in the lcc.When the physician attempted to pull back on the distal filter slider to recapture the distal filter, the distal filter slider disconnected from the sentinel cps.One (1) to two (2) mm of the tip of the distal filter was not able to be recaptured prior to the removal of the sentinel cps.Upon removal of the sentinel cps, the kinked portion of the ads became caught on the radial sheath.The sheath and sentinel cps were removed from the patient as one unit.Upon removal from the patient, the proximal and distal filters of the sentinel cps were fully recaptured.The tavi procedure was completed successfully without the use of sentinel cps.No patient complications were reported.

Manufacturer Narrative

H3 device evaluated by mfr.: the sentinel cps was returned and analyzed by a bsc quality technician.Visual analysis revealed an unsheathed proximal filter, kinked articulating distal sheath (ads), unsheathed distal filter, detached distal filter slider (#3), kinked front handle lock, kinked distal filter, and torn proximal filter.A functional test was performed and found that the distal filter could not be unsheathed while using distal filter slider (#3) as the distal filter slider (#3) was detached.

Event Description

It was reported that a distal filter dislodgement and difficulty removing the device occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter of the sentinel cps was deployed in brachiocephalic artery and the distal filter was deployed in the left common carotid (lcc) artery.During removal of the balloon aortic valvuloplasty (bav) balloon, the distal filter became disengaged from the lcc.Distal filter repositioning was reattempted, however, the articulating distal sheath (ads) kinked, and the distal filter was not able to redeploy in the lcc.When the physician attempted to pull back on the distal filter slider to recapture the distal filter, the distal filter slider disconnected from the sentinel cps.One (1) to two (2) mm of the tip of the distal filter was not able to be recaptured prior to the removal of the sentinel cps.Upon removal of the sentinel cps, the kinked portion of the ads became caught on the radial sheath.The sheath and sentinel cps were removed from the patient as one unit.Upon removal from the patient, the proximal and distal filters of the sentinel cps were fully recaptured.The tavi procedure was completed successfully without the use of sentinel cps.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17828123
• MDR Text Key: 324407141
• Report Number: 2124215-2023-52258
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0031667127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 94 YR
• Patient Sex: Female
• Patient Race: White