MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM; 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 03/01/2019

Event Type  Injury  

Manufacturer Narrative

The event date has been estimated to be (b)(6) 2019 based on the aware date of (b)(6) 2019, as the exact event date is unknown.

Event Description

It was reported a stroke occurred.The patients medical history was significant for stroke.Heparin was given to the patient before the procedure.Several times during the procedure, the patients blood pressure dropped into the 40s.The patient was given chest compressions to bring up the blood pressure.There were no issues with deploying or removing the sentinel device.The physician thought that the procedure was done and removed the sentinel device.The physician then proceeded to perform a post-dilatation on the implanted valve without the sentinel device deployed.72 hours after the procedure, the patient had an ischemic stroke, located on the right side.The patient experienced temporary paralysis.Thrombolytics were given to treat the stroke and the patient regained movement after two hours.The patient is now fine.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer (Section G): CLARET MEDICAL, INC.; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8532831
• MDR Text Key: 142532925
• Report Number: 2134265-2019-04015
• 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: 04/19/2019

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 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: 03/28/2019
• Initial Date FDA Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention