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

Model Number CMS15-10C

Device Problems Positioning Failure (1158); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that proximal filter dislodgement in a deployed state occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in the brachiocephalic artery.The proximal filter moved out of the brachiocephalic artery into the artery while in the deployed state.The proximal filter was recaptured and deployed again in the brachiocephalic artery in a more distal position.The proximal filter was recaptured a third time, however when attempting to re-deploy, the proximal filter slider was stiff and would not slide.The sentinel cps was removed from the patient's vasculature and the tavi procedure proceeded without the use of a sentinel cps.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the returned device consisted of a sentinel cerebral protection system (cps).Visual inspection revealed the proximal filter was sheathed, the articulating distal sheath (ads) was relaxed, the distal filter was unsheathed, the sentinel cps was returned with a guidewire loaded and the distal filter slider (#3) was bent/kinked.A functional test was performed; the proximal filter could not be un-sheathed, and resistance was felt.The reported issue of proximal filter failure to deploy was confirmed.Product analysis could not confirm the reported failure to maintain position/reposition as clinical circumstances could not be replicated, thus the cause is not established.

Event Description

It was reported that proximal filter dislodgement in a deployed state occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in the brachiocephalic artery.The proximal filter moved out of the brachiocephalic artery into the aorta while in the deployed state.The proximal filter was recaptured and deployed again in the brachiocephalic artery in a more distal position.The proximal filter was recaptured a third time, however when attempting to re-deploy, the proximal filter slider was stiff and would not slide.The sentinel cps was removed from the patient's vasculature and the tavi procedure proceeded without the use of a sentinel cps.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16587785
• MDR Text Key: 311757709
• Report Number: 2124215-2023-09130
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2024
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0029409567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1