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

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that a cerebral vascular accident (cva) occurred.The patient was on a periprocedural, anticoagulant medication regimen.A sentinel cerebral protection system (cps) was being used in a radiofrequency, pulmonary vein isolation (pvi) procedure for treatment of paroxysmal atrial fibrillation.The sentinel cps was prepared, inserted, and deployed successfully in its intended location.An intravenous anti-coagulant was given during the procedure.It was noted the patient experienced a short episode of hypotension during pvi ablation related to bradycardia during the ablation.The sentinel cps was removed from the patient upon the conclusion of the procedure.The total procedure time was 4 hours and 14 minutes.The sentinel cps device was implanted for 90 minutes and an additional 10 minutes for removal.One hour after the conclusion of the procedure in the post procedure recovery unit, the patient experienced a second episode of hypotension which was likely attributed to a vagal episode during recovery from anesthesia.It was then noted that neurologic changes occurred, with right upper extremity and left lower extremity weakness.Imaging was performed and revealed the symptoms were related to a cva.In the physician's opinion, the cause of the cva was cerebral hypoperfusion leading to watershed infarcts.This manifested as multiple areas of cortical infarcts in the bilateral hemispheres of the brain and multiple neurological deficits in the patient.The short periods of hypotension experienced by the patient during the procedure combined with the presence of the sentinel cps device in the anterior circulation were the likely etiology of the cva per the physician.The patient was given brain physical rehabilitation and speech therapy and was discharged fourteen (14) days post index procedure.

• 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: 18650384
• MDR Text Key: 334648560
• Report Number: 2124215-2024-06083
• Device Sequence Number: 1
• Product Code: PUM
• 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
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0030482840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other