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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
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CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C-US
Device Problem Positioning Failure (1158)
Patient Problems Stroke/CVA (1770); No Consequences Or Impact To Patient (2199)
Event Date 03/31/2020
Event Type  Injury  
Event Description
It was reported that a stroke occurred.A sentinel cerebral protection system was used during a lotus edge valve implant procedure.Only the proximal filter was deployed.An attempt was made to deploy the distal filter, however, the anatomy was difficult.Three (3) days post procedure, the patient experienced a stroke originating in posterior basal.Patient presented with symptoms of dizziness and confusion, both of which resolved the same day.The patient was started on coumadin following the stroke.The patient has been discharged home and is undergoing rehab therapy.
 
Manufacturer Narrative
B5 describe event or problem: updated.H6 patient codes: updated.
 
Event Description
It was reported that a stroke occurred.A sentinel cerebral protection system was used during a lotus edge valve implant procedure.Only the proximal filter was deployed.An attempt was made to deploy the distal filter, however, the anatomy was difficult.Three (3) days post procedure, the patient experienced a stroke originating in posterior basal.Patient presented with symptoms of dizziness and confusion, both of which resolved the same day.The patient was started on coumadin following the stroke.The patient has been discharged home and is undergoing rehab therapy.It was further reported that the stroke originated from a vessel not protected by the sentinel cerebral protection system, therefore, there is no stroke allegation against the sentinel device.
 
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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
MDR Report Key10018272
MDR Text Key189637697
Report Number2134265-2020-05808
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
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 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/26/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025293855
Was Device Available for Evaluation? No
Date Manufacturer Received05/07/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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