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 Problems Stroke/CVA (1770); Death (1802); Eye Injury (1845); Hemorrhage, Cerebral (1889)

Event Date 02/13/2020

Event Type  Death  

Event Description

It was reported that a cerebral vascular accident, ocular injury, cerebral hemorrhage, and death occurred.A sentinel cerebral protection system was selected for use during a mitral valve-in-valve procedure.Heparin was given.The sentinel cerebral protection system was inserted and deployed the patients right brachial artery and left common corradit artery.The sentinel was deployed within two (2) minutes without issue.The physicians then implanted a 20mm non boston scientific valve.Once the valve was in place and they were happy with the result, the sentinel device was retrieved with ease.The patient was doing well and moving all four (4) extremities while waking up from anesthesia.It was then noticed that she had blown one of her pupils.An immediate computed tomography was performed and revealed a minor brain bleed and evidence of an embolic stroke.The patient passed away later that day.

• 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; suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9855966
• MDR Text Key: 184144238
• Report Number: 2134265-2020-02403
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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
• Date Manufacturer Received: 02/19/2020
• 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): Death
• Patient Age: 7 YR