MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM

Model Number 10418

Device Problems Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Arrhythmia (1721); Stroke/CVA (1770); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/13/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that 1st degree atrioventricular (av) block, right bundle branch block(rbbb) and a cerebral vascular accident (cva) occurred.Procedure summary: prior to the index procedure, heparin or other anticoagulant was given.The subject was on a prior regimen of aspirin and other antiplatelet medication at the time of index procedure.An isleeve introducer was placed and then the native aortic valve was treated with balloon valvuloplasty(bav), according to the instructions for use(ifu).A 23 mm lotus edge valve (lot# 24763203) was initially inserted but not implanted as the post was twisted prior to pause to lock and at pause to lock phase.Multiple partial resheaths were attempted.The first 23 mm lotus edge valve (lot# 24763203) was successfully retrieved and then the native aortic valve was treated with the deployment of a second 23 mm lotus edge valve (lot# 24802190) involving successful repositioning of the second 23 mm lotus edge valve (lot# 24802190) with partial re-sheathing of the valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.Post procedure event summary: on the same day post index procedure, electrocardiogram(ecg) revealed 1st degree av block and right bundle branch block.Temporary pacemaker was placed to treat the event.Three (3) days post index procedure, the subject experienced 3 episodes of aphasia with difficulty finding words.Stoke code was initiated.Neurological examination revealed alert, expressive aphasia and recommended to start on heparin gtt.Heparin was switched to bolus direct oral anticoagulant(doac).On the same day, a mri scan (magnetic resonance imaging) of the brain with and without contrast revealed a small peripheral cortical and sub cortical area of restricted diffusion was seen in the premotor left frontal lobe at the posterior end of the middle frontal gyrus where findings indicate a small acute infarct.Curvilinear enhancement was noted in the sulcus along the infract and this is likely representing an enhancing vein that is compressed.Subject was then diagnosed with acute stoke.The suspected etiology is cardioembolic.At the time of reporting, the event was considered recovering.Five (5) days post index procedure, the subject was discharged on aspirin and is well at home.

Event Description

Reprise iv study.It was reported that 1st degree atrioventricular (av) block, right bundle branch block(rbbb) and a cerebral vascular accident (cva) occurred.Procedure summary: prior to the index procedure, heparin or other anticoagulant was given.The subject was on a prior regimen of aspirin and other antiplatelet medication at the time of index procedure.An isleeve introducer was placed and then the native aortic valve was treated with balloon valvuloplasty(bav), according to the instructions for use(ifu).A 23 mm lotus edge valve (lot# 24763203) was initially inserted but not implanted as the post was twisted prior to pause to lock and at pause to lock phase.Multiple partial resheaths were attempted.The first 23 mm lotus edge valve (lot# 24763203) was successfully retrieved and then the native aortic valve was treated with the deployment of a second 23 mm lotus edge valve (lot# 24802190) involving successful repositioning of the second 23 mm lotus edge valve (lot# 24802190) with partial re-sheathing of the valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.Post procedure event summary: on the same day post index procedure, electrocardiogram(ecg) revealed 1st degree av block and right bundle branch block.Temporary pacemaker was placed to treat the event.Three (3) days post index procedure, the subject experienced 3 episodes of aphasia with difficulty finding words.Stoke code was initiated.Neurological examination revealed alert, expressive aphasia and recommended to start on heparin gtt.Heparin was switched to bolus direct oral anticoagulant(doac).On the same day, a mri scan (magnetic resonance imaging) of the brain with and without contrast revealed a small peripheral cortical and sub cortical area of restricted diffusion was seen in the premotor left frontal lobe at the posterior end of the middle frontal gyrus where findings indicate a small acute infarct.Curvilinear enhancement was noted in the sulcus along the infract and this is likely representing an enhancing vein that is compressed.Subject was then diagnosed with acute stoke.The suspected etiology is cardioembolic.At the time of reporting, the event was considered recovering.Five (5) days post index procedure, the subject was discharged on aspirin and is well at home.It was further reported that: 34 days post index procedure, during the 30 day follow up visit, echocardiogram revealed high mean pressure gradient.No action was taken to treat the event.At the time of reporting, the event was considered not recovered.

Manufacturer Narrative

H3: device eval by manufacturer: the lotus edge valve system device was returned to boston scientific and analyzed by a bsc quality engineer.Upon visual inspection, the device was returned with the bottle attached.A visible kink was noted on the nosecone extension at the location of the bottle cap.The bottle was then removed.The distal outer sheath tip was damaged.The nosecone extension was kinked at multiple locations.There was approximately 4cm of a safari guidewire protruding from the nosecone.There was no valve attached, as it was implanted during the procedure.The outer sheath was cut to expose the multi lumen extrusion (mle) to locate the guidewire.The proximal tip of the guidewire was located, and the coils did not appear displaced.The length of the guidewire within the device was approximately 44.5cm.The available procedural angiographic media is consistent with the reported event.Balloon aortic valvuloplasty (bav) is performed on the calcified annulus.A lotus edge valve is unsheathed in the annulus.On unsheathing the center post, post six appears to be twisted as the tuning fork is not visible.The media does not provide recordings of the re-positioning's and there are multiple time-lapses between the 16 series provided.The second valve was initially positioned asymmetrically, however after another time-lapse the second valve was released in a suitable location with no visible evidence of valvular insufficiency.

Event Description

Reprise iv study: it was reported that 1st degree atrioventricular (av) block, right bundle branch block(rbbb) and a cerebral vascular accident (cva) occurred.Procedure summary: prior to the index procedure, heparin or other anticoagulant was given.The subject was on a prior regimen of aspirin and other antiplatelet medication at the time of index procedure.An isleeve introducer was placed and then the native aortic valve was treated with balloon valvuloplasty(bav), according to the instructions for use(ifu).A 23 mm lotus edge valve (lot# 24763203) was initially inserted but not implanted as the post was twisted prior to pause to lock and at pause to lock phase.Multiple partial resheaths were attempted.The first 23 mm lotus edge valve (lot# 24763203) was successfully retrieved and then the native aortic valve was treated with the deployment of a second 23 mm lotus edge valve (lot# 24802190) involving successful repositioning of the second 23 mm lotus edge valve (lot# 24802190) with partial re-sheathing of the valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus.Post procedure event summary: on the same day post index procedure, electrocardiogram(ecg) revealed 1st degree av block and right bundle branch block.Temporary pacemaker was placed to treat the event.Three (3) days post index procedure, the subject experienced 3 episodes of aphasia with difficulty finding words.Stroke code was initiated.Neurological examination revealed alert, expressive aphasia and recommended to start on heparin gtt.Heparin was switched to bolus direct oral anticoagulant (doac).On the same day, a mri scan (magnetic resonance imaging) of the brain with and without contrast revealed a small peripheral cortical and sub cortical area of restricted diffusion was seen in the premotor left frontal lobe at the posterior end of the middle frontal gyrus where findings indicate a small acute infarct.Curvilinear enhancement was noted in the sulcus along the infract and this is likely representing an enhancing vein that is compressed.Subject was then diagnosed with acute stoke.The suspected etiology is cardioembolic.At the time of reporting, the event was considered recovering.Five (5) days post index procedure, the subject was discharged on aspirin and is well at home.It was further reported that: 34 days post index procedure, during the 30 day follow up visit, echocardiogram revealed high mean pressure gradient.No action was taken to treat the event.At the time of reporting, the event was considered not recovered.It was further reported that the origin of the stroke was unclear.After diagnosis of a stroke, the patient was continued on 81 mg of aspirin, 75 mg of plavix along with atorvastatin and was started on heparin without bolus with doac.Five days post index procedure, the patient was discharged on aspirin and clopidogrel.Thirty four days post index procedure, the stroke was considered recovered.

Manufacturer Narrative

The lotus edge valve system device was returned to boston scientific and analyzed by a bsc quality engineer.Upon visual inspection, the device was returned with the bottle attached.A visible kink was noted on the nosecone extension at the location of the bottle cap.The bottle was then removed.The distal outer sheath tip was damaged.The nosecone extension was kinked at multiple locations.There was approximately 4cm of a safari guidewire protruding from the nosecone.There was no valve attached, as it was implanted during the procedure.The outer sheath was cut to expose the multi lumen extrusion (mle) to locate the guidewire.The proximal tip of the guidewire was located, and the coils did not appear displaced.The length of the guidewire within the device was approximately 44.5cm.The available procedural angiographic media is consistent with the reported event.Balloon aortic valvuloplasty (bav) is performed on the calcified annulus.A lotus edge valve is unsheathed in the annulus.On unsheathing the center post, post six appears to be twisted as the tuning fork is not visible.The media does not provide recordings of the re-positioning's and there are multiple time-lapses between the 16 series provided.The second valve was initially positioned asymmetrically, however after another time-lapse the second valve was released in a suitable location with no visible evidence of valvular insufficiency.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10549228
• MDR Text Key: 207506779
• Report Number: 2134265-2020-12828
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0024802190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 03/19/2021
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR