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

Event Date 12/17/2019

Event Type  Injury  

Event Description

It was reported that stroke occurred.The subject was on a prior regimen aspirin and antiplatelet medication other than aspirin at the time of index procedure.Prior to the index procedure, heparin or other anticoagulant was given.The subject received a loading doses of 81 mg of aspirin and 300 mg of clopidogrel.A sentinel cerebral protection system was placed.A lotus introducer was inserted and then the native aortic valve was treated balloon valvuloplasty.A 27 mm lotus edge valve was advanced.When the deployment of the 27 mm lotus edge valve began; the deployment was not coaxial.The subject was suddenly hypotensive and cpr was initiated.The valve was withdrawn, subject resuscitated and intubated.Once the subject was stabilized the transaortic valve implant (tavi) procedure was continued.Then the aortic valve was treated with and subsequent deployment of the 27 mm lotus edge valve.Successful positioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.It was also noted that the subject had asystole for 5-10 min with return of spontaneous circulation during procedure.On the same day of the index procedure, the subject developed cardiac arrhythmia.Electrocardiogram (ecg) revealed first degree arteriovenous (av) block and left bundle branch block (lbbb).A non-bsc permanent pacemaker was successfully implanted on the same day.Medication was given to the subject to treat the hypotension.At the time of reporting, the hypotension was considered to have not resolved.One (1) day post index procedure, the subject was off sedation since 8 am.Stroke alert was called at 5pm as he was not moving the left side to noxious stimuli.Computed tomography angiography was recommended and it revealed acute to subacute infarct involving the left temporo-occipital lobe infarct with localized mass effect and effacement of the temporal horn of the left lateral ventricle.No findings to suggest the hemorrhagic transformation, small hypodensity within the right frontal corona radiata which is unchanged from prior related to an age indeterminate infarct.At the time of reporting, the event subacute infarct was considered recovering/ resolving.

Manufacturer Narrative

B5: describe event or problem: updated with additional information.B6: relevant test / laboratory data: updated with additional information.

Event Description

It was reported that stroke occurred.The subject was on a prior regimen aspirin and antiplatelet medication other than aspirin at the time of index procedure.Prior to the index procedure, heparin or other anticoagulant was given.The subject received a loading doses of 81 mg of aspirin and 300 mg of clopidogrel.A sentinel cerebral protection system was placed.A lotus introducer was inserted and then the native aortic valve was treated balloon valvuloplasty.A 27 mm lotus edge valve was advanced.When the deployment of the 27 mm lotus edge valve began; the deployment was not coaxial.The subject was suddenly hypotensive and cpr was initiated.The valve was withdrawn, subject resuscitated and intubated.Once the subject was stabilized the transaortic valve implant (tavi) procedure was continued.Then the aortic valve was treated with and subsequent deployment of the 27 mm lotus edge valve.Successful positioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.It was also noted that the subject had asystole for 5-10 min with return of spontaneous circulation during procedure.On the same day of the index procedure, the subject developed cardiac arrhythmia.Electrocardiogram (ecg) revealed first degree arteriovenous (av) block and left bundle branch block (lbbb).A non-bsc permanent pacemaker was successfully implanted on the same day.Medication was given to the subject to treat the hypotension.At the time of reporting, the hypotension was considered to have not resolved.One (1) day post index procedure, the subject was off sedation since 8 am.Stroke alert was called at 5pm as he was not moving the left side to noxious stimuli.Computed tomography angiography was recommended and it revealed acute to subacute infarct involving the left temporo-occipital lobe infarct with localized mass effect and effacement of the temporal horn of the left lateral ventricle.No findings to suggest the hemorrhagic transformation, small hypodensity within the right frontal corona radiata which is unchanged from prior related to an age indeterminate infarct.At the time of reporting, the event subacute infarct was considered recovering/ resolving.It was further reported that one (1) day post index procedure, computed tomography (ct) perfusion revealed findings related to a core infarct involving evolving left temporal occipital lobe without area of tissue at risk.Ct angiogram showed significant calcific atherosclerotic changes involving bilateral carotid bifurcations with approximately 60% stenosis involving the proximal right internal carotid artery and 55% stenosis involving the proximal left internal carotid artery.Bilateral vertebral arteries were patent without aneurysm/pseudoaneurysm, dissection, thrombosis or flow limiting stenosis.Partially imaged bilateral effusions were noted.Two (2) days post indx procedure, upon neurological consultation the subject was observed to have stroke, which did not appear to be manifesting itself clinically on exam.Stroke, with an element of hypoxic encephalopathy was also noted.Three (3) days post index procedure, neurological exam revealed that the attention span and concentration, orientation, language and remote memory were nearly nil.The nurse stated that the subject could only squeeze left hand, but it was weaker.The subject was noted to have movement on the right side than on the left.Chest x-ray showed bilateral pleural effusion, interstitial pulmonary edema, which the site confirmed was attributed to bilateral pulmonary edema.Eight (8) days post index procedure, neurological exam revealed infarcts involving bilateral cerebellar hemisphere, depressed but symmetrical reflexes, dulled sensation on the left side and left sided muscle weakness.Twenty four (24) days post index procedure, the stroke was considered to be resolving and the subject was discharged on aspirin.

Event Description

It was further reported that the stoke was not related to the sentinel cerebral protection system and the event has been withdrawn.It was reported that stroke occurred.The subject was on a prior regimen aspirin and antiplatelet medication other than aspirin at the time of index procedure.Prior to the index procedure, heparin or other anticoagulant was given.The subject received a loading doses of 81 mg of aspirin and 300 mg of clopidogrel.A sentinel cerebral protection system was placed.A lotus introducer was inserted and then the native aortic valve was treated balloon valvuloplasty.A 27 mm lotus edge valve was advanced.When the deployment of the 27 mm lotus edge valve began; the deployment was not coaxial.The subject was suddenly hypotensive and cpr was initiated.The valve was withdrawn, subject resuscitated and intubated.Once the subject was stabilized the transaortic valve implant (tavi) procedure was continued.Then the aortic valve was treated with and subsequent deployment of the 27 mm lotus edge valve.Successful positioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.It was also noted that the subject had asystole for 5-10 min with return of spontaneous circulation during procedure.On the same day of the index procedure, the subject developed cardiac arrhythmia.Electrocardiogram (ecg) revealed first degree arteriovenous (av) block and left bundle branch block (lbbb).A non-bsc permanent pacemaker was successfully implanted on the same day.Medication was given to the subject to treat the hypotension.At the time of reporting, the hypotension was considered to have not resolved.One (1) day post index procedure, the subject was off sedation since 8 am.Stroke alert was called at 5pm as he was not moving the left side to noxious stimuli.Computed tomography angiography was recommended and it revealed acute to subacute infarct involving the left temporo-occipital lobe infarct with localized mass effect and effacement of the temporal horn of the left lateral ventricle.No findings to suggest the hemorrhagic transformation, small hypodensity within the right frontal corona radiata which is unchanged from prior related to an age indeterminate infarct.At the time of reporting, the event subacute infarct was considered recovering/ resolving.It was further reported that one (1) day post index procedure, computed tomography (ct) perfusion revealed findings related to a core infarct involving evolving left temporal occipital lobe without area of tissue at risk.Ct angiogram showed significant calcific atherosclerotic changes involving bilateral carotid bifurcations with approximately 60% stenosis involving the proximal right internal carotid artery and 55% stenosis involving the proximal left internal carotid artery.Bilateral vertebral arteries were patent without aneurysm/pseudoaneurysm, dissection, thrombosis or flow limiting stenosis.Partially imaged bilateral effusions were noted.Two (2) days post indx procedure, upon neurological consultation the subject was observed to have stroke, which did not appear to be manifesting itself clinically on exam.Stroke, with an element of hypoxic encephalopathy was also noted.Three (3) days post index procedure, neurological exam revealed that the attention span and concentration, orientation, language and remote memory were nearly nil.The nurse stated that the subject could only squeeze left hand, but it was weaker.The subject was noted to have movement on the right side than on the left.Chest x-ray showed bilateral pleural effusion, interstitial pulmonary edema, which the site confirmed was attributed to bilateral pulmonary edema.Eight (8) days post index procedure, neurological exam revealed infarcts involving bilateral cerebellar hemisphere, depressed but symmetrical reflexes, dulled sensation on the left side and left sided muscle weakness.Twenty four (24) days post index procedure, the stroke was considered to be resolving and the subject was discharged on aspirin.

Manufacturer Narrative

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

• 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: 9599239
• MDR Text Key: 175913296
• Report Number: 2134265-2019-16605
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR