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 02/14/2019

Event Type  Injury  

Event Description

It was reported that a patient stroke occurred.During a transcatheter aortic valve replacement (tavr) procedure, a sentinel cerebral protection system was deployed in the patient's innominate and right common carotid arteries without incident in 4.5 minutes.After a successful tavr procedure concluded, the sentinel device was removed from the patient without incident.The patient appeared to be having a hard time waking up after the procedure.This was initially believed to be due to the anesthesia but was soon recognized as suffering from an acute episode.Magnetic resonance imaging (mri) was performed and confirmed the stroke.The patient has made improvements and has started rehabilitation.

• 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): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer Contact: sonali arangil ; two scimed place; ,; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8407934
• MDR Text Key: 138382320
• Report Number: 2134265-2019-02160
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 18L13H08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2019
• Initial Date FDA Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 89 YR