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

Model Number CMS15-10C-US

Device Problems Device-Device Incompatibility (2919); Positioning Problem (3009)

Patient Problem Transient Ischemic Attack (2109)

Event Date 01/24/2022

Event Type  Injury  

Event Description

It was reported that the distal filter was pulled out of position in an open state and a transient ischemic attack (tia) occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter and distal filters of the sentinel cps were successfully deployed.During the tavi procedure, the articulating sheath of the sentinel cps became caught on the non-bsc valve delivery system, and the distal filter of the sentinel cps was pulled out of position in an open state.The distal filter was successfully recaptured.The physician elected to proceed with only the proximal filter of the sentinel cps deployed.The tavi procedure was completed.A few hours post procedure, the patient had confusion, and magnetic resonance imaging (mri) scan revealed new brain lesions.The patient experienced a tia with residual short term memory problems.The patient was discharged home after most symptoms resolved and was expected to fully recover.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE CR, SRL; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13483603
• MDR Text Key: 285257476
• Report Number: 2134265-2022-01212
• 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: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Female