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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE
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CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 07/02/2019
Event Type  Injury  
Event Description
It was reported that a stroke occurred.Procedure summary: access was obtained via the left femoral artery.A sentinel embolic protection device was fully deployed without any reported issues.A lotus edge valve delivery system was advanced to the aortic valve.The valve was repositioned a few times with one full resheath before deploying in the correct position in accordance with the dfu.Event summary: a few hours post procedure, the patient was unable to see the food in front of them self.The patient was treated for a mild embolic stroke with medication and is continuing to be monitored.
 
Event Description
It was reported that a stroke occurred.Procedure summary: access was obtained via the left femoral artery.A sentinel embolic protection device was fully deployed without any reported issues.A lotus edge valve delivery system was advanced to the aortic valve.The valve was repositioned a few times with one full resheath before deploying in the correct position in accordance with the dfu.Event summary: a few hours post procedure, the patient was unable to see the food in front of them self.The patient was treated for a mild embolic stroke with medication and is continuing to be monitored.It was further reported that at one month follow up, the patient had no residual deficits and their vision was back to normal.
 
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Brand Name
SENTINEL CEREBRAL PROTECTION SYSTEM
Type of Device
EMBOLIC PROTECTION DEVICE
Manufacturer (Section D)
CLARET MEDICAL, INC.
1745 copperhill parkway
santa rosa CA 95403
MDR Report Key8861300
MDR Text Key153282889
Report Number2134265-2019-09164
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
PMA/PMN Number
DEN160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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