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 06/04/2020

Event Type  Injury  

Event Description

It was reported that stroke occurred.An aortogram was performed to assess the arch anatomy.A sentinel embolic protection device was advanced.The physician was able to deploy the proximal filter.While attempting to position the distal filter, the angle of the left common carotid was noted to be challenging.The distal filter was not able to be positioned due to the anatomical challenges.The physician elected to proceed with only the proximal filter deployed.The remainder of the sentinel embolic protection device was pulled back so that it would not interfere with the transcatheter aortic valve replacement devices.A non-bsc valve was implanted.Two days later, the patient was ambulating and getting ready to be discharged when the patient experienced blurred vision, was unsteady on her feet, and ran into a wall.A day later, the patient presented to the emergency room (er).Neurology was consulted.A computed tomography (ct) head scan demonstrated a subacute right parasagittal occipital lobe infarct.No specific meds were administered to treat the blurred vision.The patient spent approximately one week within a formal rehab facility.The patient was discharged and is doing well.

• 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: 10279692
• MDR Text Key: 199056548
• Report Number: 2134265-2020-09306
• Device Sequence Number: 1
• Product Code: PUM
• 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: 07/15/2020

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 Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/15/2020
• 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: 74 YR