MAUDE Adverse Event Report: CLARET MEDICAL, INC. 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 Problem Stroke/CVA (1770)

Event Date 02/13/2020

Event Type  Injury  

Event Description

It was reported that a cerebrovascular accident(cva) occurred.A sentinel cerebral protection system was selected for a transcatheter aortic valve replacement(tavr) procedure.48 hours post procedure, the patient had an acute right sided cva.The findings were: moderately large area of infarction involving right parietal lobe and insular cortex with additional small foci in the left frontal white matter.According to the healthcare professional, this is consistent with acute or subacute infarction.The patient was on aspirin and plavix previously, so these medications were continued to treat the cva.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 160 knowles drive; los gatos CA 95032
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9850605
• MDR Text Key: 184040520
• Report Number: 2134265-2020-02382
• 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: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19G08H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other