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

Model Number CMS15-10C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  Injury  

Event Description

(b)(6) study it was reported that stroke occurred.Procedure summary: the subject was enrolled into the reprise iii study in february 2020 and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the subject was not on prior regimen of aspirin and antiplatelet at the time of index procedure.The subject received loading doses of 300 mg of aspirin and 300 mg of clopidogrel.A sentinel embolic protection system was placed.A lotus introducer was placed and then the aortic valve was treated with balloon valvuloplasty (bav).The subject developed complete heart block with ventricular escape post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.The complete heart block with ventricular escape, persisted post transcatheter aortic valve replacement (tavr).There was correct positioning of a single prosthetic heart valve into the proper anatomical location and neither repositioning nor retrieval was attempted.On the same day as the index procedure, during tavr, the subject was noted non responsive, slightly weak the right side with reduced glasgow coma scale and aphasia.The subject was hospitalized for further evaluation.Neurological exam revealed normal cerebellar function with abnormal reflexes, cranial nerves, sensations and muscle strength.Nihss was 6.Computed tomography (ct) and magnetic resonance imaging (mri) scans revealed stroke.The stroke was ischemic.The cause of the ischemic stroke is unknown.The event was treated medically.In (b)(6) 2020, the subject was in good condition and on the same day, the subject was discharged at home on aspirin.

Manufacturer Narrative

B5: describe event or problem, updated.B6: relevant tests/laboratory data, updated.

Event Description

Reprise iii study.It was reported that stroke occurred.Procedure summary: the subject was enrolled into the reprise iii study on (b)(6) 2020 and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the subject was not on prior regimen of aspirin and antiplatelet at the time of index procedure.The subject received loading doses of 300 mg of aspirin and 300 mg of clopidogrel.A sentinel embolic protection system was placed.A lotus introducer was placed and then the aortic valve was treated with balloon valvuloplasty (bav).The subject developed complete heart block with ventricular escape post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.The complete heart block with ventricular escape, persisted post transcatheter aortic valve replacement (tavr).There was correct positioning of a single prosthetic heart valve into the proper anatomical location and neither repositioning nor retrieval was attempted.On the same day as the index procedure, during tavr, the subject was noted non responsive, slightly weak the right side with reduced glasgow coma scale and aphasia.The subject was hospitalized for further evaluation.Neurological exam revealed normal cerebellar function with abnormal reflexes, cranial nerves, sensations and muscle strength.Nihss was 6.Computed tomography (ct) and magnetic resonance imaging (mri) scans revealed stroke.The stroke was ischemic.The cause of the ischemic stroke is unknown.The event was treated medically.On (b)(6) 2020, the subject was in good condition and on the same day, the subject was discharged at home on aspirin.It was further reported on (b)(6) 2020, the mrs_90 days score was 1 which indicates no significant disability despite symptoms; able to carry out all usual duties and activities.

Manufacturer Narrative

B5 describe event or problem - updated.H6 patient codes - updated.

Event Description

It was further reported that the causality was downgraded as not applicable to sentinel.Reprise iii study: it was reported that stroke occurred.Procedure summary: the subject was enrolled into the reprise iii study in (b)(6) 2020 and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the subject was not on prior regimen of aspirin and antiplatelet at the time of index procedure.The subject received loading doses of 300 mg of aspirin and 300 mg of clopidogrel.A sentinel embolic protection system was placed.A lotus introducer was placed and then the aortic valve was treated with balloon valvuloplasty (bav).The subject developed complete heart block with ventricular escape post bav.The aortic valve was treated with deployment of a 27 mm lotus edge valve.The complete heart block with ventricular escape, persisted post transcatheter aortic valve replacement (tavr).There was correct positioning of a single prosthetic heart valve into the proper anatomical location and neither repositioning nor retrieval was attempted.On the same day as the index procedure, during tavr, the subject was noted non responsive, slightly weak the right side with reduced glasgow coma scale and aphasia.The subject was hospitalized for further evaluation.Neurological exam revealed normal cerebellar function with abnormal reflexes, cranial nerves, sensations and muscle strength.Nihss was 6.Computed tomography (ct) and magnetic resonance imaging (mri) scans revealed stroke.The stroke was ischemic.The cause of the ischemic stroke is unknown.The event was treated medically.In (b)(6) 2020, the subject was in good condition and on the same day, the subject was discharged at home on aspirin.It was further reported in (b)(6) 2020, the mrs_90 days score was 1 which indicates no significant disability despite symptoms; able to carry out all usual duties and activities.

• 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 Key: 9838368
• MDR Text Key: 183727295
• Report Number: 2134265-2020-02664
• Device Sequence Number: 1
• Product Code: PUM
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR