MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C-US

Device Problems Device-Device Incompatibility (2919); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

(b)(6) study.It was reported that the distal filter failed to maintain position.Prior to the index procedure, heparin or another anticoagulant was given.The subject was on a prior regimen of aspirin and antiplatelet medication other than aspirin at the time of index procedure.After heparin had been given and prior to sentinel device insertion, the activated clotting time (act) was 288 sec.An introducer sheath was placed into the radial artery and a sentinel cerebral protection system was inserted with the proximal filter into brachiocephalic artery, and distal filter in the left common carotid artery.The native aortic valve was treated with deployment of a non-bsc prosthetic valve into the correct anatomical location.However, the distal filter of the sentinel cerebral protection system dislodged prior to completion of the procedure.When the valve was being moved through the anatomy, it touched the sentinel cerebral protection system wire and moved the distal filter.The distal filter was able to be redeployed into the left common carotid artery.Recapture of the distal filter was not required and the sentinel cerebral protection system was retrieved successfully, without complications.One day post index procedure, the subject was discharged home on 81 mg of aspirin and 75 mg of clopidogrel.

Manufacturer Narrative

B5: describe event or problem: updated.B7: other relevant history: updated.

Event Description

Protected tavr study.It was reported that the distal filter failed to maintain position.Prior to the index procedure, heparin or another anticoagulant was given.The subject was on a prior regimen of aspirin and antiplatelet medication other than aspirin at the time of index procedure.After heparin had been given and prior to sentinel device insertion, the activated clotting time (act) was 288 sec.An introducer sheath was placed into the radial artery and a sentinel cerebral protection system was inserted with the proximal filter into brachiocephalic artery, and distal filter in the left common carotid artery.The native aortic valve was treated with deployment of a non-bsc prosthetic valve into the correct anatomical location.However, the distal filter of the sentinel cerebral protection system dislodged prior to completion of the procedure.When the valve was being moved through the anatomy, it touched the sentinel cerebral protection system wire and moved the distal filter.The distal filter was able to be redeployed into the left common carotid artery.Recapture of the distal filter was not required and the sentinel cerebral protection system was retrieved successfully, without complications.One day post index procedure, the subject was discharged home on 81 mg of aspirin and 75 mg of clopidogrel.It was further reported that upon dislodgement, the distal filter of the sentinel device was at the ostium of the left common carotid(lcc) and not hanging in the aortic arch.The distal filter was then able to be redeployed.

Manufacturer Narrative

B6: relevant tests/laboratory data: updated.

Event Description

Protected tavr study.It was reported that the distal filter failed to maintain position.Prior to the index procedure, heparin or another anticoagulant was given.The subject was on a prior regimen of aspirin and antiplatelet medication other than aspirin at the time of index procedure.After heparin had been given and prior to sentinel device insertion, the activated clotting time (act) was 288 sec.An introducer sheath was placed into the radial artery and a sentinel cerebral protection system was inserted with the proximal filter into brachiocephalic artery, and distal filter in the left common carotid artery.The native aortic valve was treated with deployment of a non-bsc prosthetic valve into the correct anatomical location.However, the distal filter of the sentinel cerebral protection system dislodged prior to completion of the procedure.When the valve was being moved through the anatomy, it touched the sentinel cerebral protection system wire and moved the distal filter.The distal filter was able to be redeployed into the left common carotid artery.Recapture of the distal filter was not required and the sentinel cerebral protection system was retrieved successfully, without complications.One day post index procedure, the subject was discharged home on 81 mg of aspirin and 75 mg of clopidogrel.

• 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 Key: 10553243
• MDR Text Key: 207531239
• Report Number: 2134265-2020-12654
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025119281
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Patient Sequence Number: 1
• Patient Age: 83 YR