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 Problem Stroke/CVA (1770)

Event Date 07/18/2019

Event Type  Injury  

Event Description

(b)(6) study.Procedure summary: prior to the index procedure, heparin or other anticoagulant was given.The subject was on a prior regimen of aspirin at the time of the index procedure.The subject did not receive any loading dose.A sentinel cerebral protection system was advanced and deployed.An acurate transfemoral deliver system was placed and then the native aortic valve was treated with balloon valvuloplasty and subsequent deployment of a small acurate neo2 aortic valve.There was correct positioning of a single prosthetic valve in the correct anatomical location.Event summary: one day post index procedure, the subject noted with difficulty in walking and weakness in right lower extremity.On examination, subject was noted with mild right leg drift on straight leg raise without formal foot drop during testing and was started with hydration and was recommended for 24-hour supervised care.At the time of an event the subject was on aspirin.Computerized tomography (ct) of head revealed age indeterminate foci of low attenuation in left fronto-parietal region.No hemorrhagic transformation.Computerized tomography angiography (cta) of head and neck revealed, no evidence of occlusion, no hemodynamically significant stenosis in neck, multifocal intracranial and extracranial atherosclerotic disease.The subject was recommended for magnetic resonance imaging (mri).National institute of health stroke score (nihss) was 2: motor function - right leg: drift, limb ataxia: present in one limb.Three days post index procedure, mri revealed, small recent non-hemorrhagic infarct in left frontoparietal subcortical white matter and small vessel disease.The subject was diagnosed with stroke.The embolic stroke was suspected and due concerned about the size and hemorrhagic transition with dual anti-platelet therapy (dapt) subject was recommended for ct.The etiology of stroke was ischemic with diagnosis based on neuroimaging.It was reported by the hospital that the patient was not resolved.Three days post index procedure, the subject was discharged on aspirin with recommendation to follow-up with neurology as an outpatient.

• 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: 9123136
• MDR Text Key: 160180963
• Report Number: 2134265-2019-11650
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR