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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM
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BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM Back to Search Results
Model Number 10394
Device Problems Structural Problem (2506); Difficult to Advance (2920)
Patient Problems Aortic Insufficiency (1715); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Stenosis (2263)
Event Date 10/27/2020
Event Type  Injury  
Event Description
It was reported that difficulty to advance, hypotension, severe aortic regurgitation and vessel occlusion occurred.Procedure summary: the patient had a bicuspid aortic valve and a horizontal aortic arch.The annulus was measured at 20.6mm.Vascular access was obtained via a right transfemoral approach.The anatomy was moderately tortuous and moderately calcified.A lotus introducer sheath (lis) was inserted into the right femoral artery.An extra small (xs) safari2 guidewire was inserted and advanced to the aortic arch without problem.A 23mmlotus edge valve delivery system (lot# 25004444) was advanced and was unable to cross the aortic valve.During removal of the 23mm lotus edge delivery system (lot #25004444), pressure was applied inside the sheath, and the delivery system catheter tip became flattened.Balloon aortic valvuloplasty(bav) was performed using 18mm non-boston scientific balloon catheter.The xs safari 2 guidewire was replaced with a small safari2 guidewire.The 23mm lotus edge valve delivery system (lot #25004444) was exchanged for another 23mm lotus edge valve delivery system (lot # 25004441).The 23mm lotus edge valve (lot: 25004441) was prepared and inserted; however the same issue occurred with the inability to cross the aortic valve.In order to orient the tip towards to the aortic valve, the delivery system was removed once using a snare.The snare wire was inserted via the femoral region.The 23mm lotus edge valve system was advanced to the ascending aorta and able to cross the aortic valve by pulling the catheter tip using the snare.During deployment of the 23mm lotus edge valve, asymmetric unsheathing occurred.A partial recapture was performed in accordance with the instructions for use (ifu).On the second deployment attempt, the 23mm lotus edge valve was able to be unsheathed and locked.When checking the locking of the lotus edge valve, st elevation was observed on the electrocardiogram(ecg).At the same time, a decrease in the patients blood pressure was noticed.A transthoracic echocardiogram(tte) was performed and indicated the right ventricle was not moving.The 23mm lotus edge valve was resheathed and removed in accordance with the ifu.Imaging was performed in the right coronary artery (rca) and left coronary artery(lca) and blood flow was able to be confirmed without any stenosis.Function of the right ventricle recovered.Vasopressors were administered, and the patients blood pressure gradually increased.At this time, severe aortic regurgitation (ar) was noted under echocardiogram.The physician determined that it would be dangerous to continue the procedure, so the procedure was discontinued.The patient was scheduled to undergo surgical aortic valve replacement three days later.
 
Event Description
It was reported that difficulty to advance, hypotension, severe aortic regurgitation and vessel occlusion occurred.Procedure summary: the patient had a bicuspid aortic valve and a horizontal aortic arch.The annulus was measured at 20.6mm.Vascular access was obtained via a right transfemoral approach.The anatomy was moderately tortuous and moderately calcified.A lotus introducer sheath (lis) was inserted into the right femoral artery.An extra small (xs) safari2 guidewire was inserted and advanced to the aortic arch without problem.A 23mmlotus edge valve delivery system (lot# 25004444) was advanced and was unable to cross the aortic valve.During removal of the 23mm lotus edge delivery system (lot #25004444), pressure was applied inside the sheath, and the delivery system catheter tip became flattened.Balloon aortic valvuloplasty(bav) was performed using 18mm non-boston scientific balloon catheter.The xs safari 2 guidewire was replaced with a small safari2 guidewire.The 23mm lotus edge valve delivery system (lot #25004444) was exchanged for another 23mm lotus edge valve delivery system (lot # 25004441).The 23mm lotus edge valve (lot: 25004441) was prepared and inserted; however the same issue occurred with the inability to cross the aortic valve.In order to orient the tip towards to the aortic valve, the delivery system was removed once using a snare.The snare wire was inserted via the femoral region.The 23mm lotus edge valve system was advanced to the ascending aorta and able to cross the aortic valve by pulling the catheter tip using the snare.During deployment of the 23mm lotus edge valve, asymmetric unsheathing occurred.A partial recapture was performed in accordance with the instructions for use (ifu).On the second deployment attempt, the 23mm lotus edge valve was able to be unsheathed and locked.When checking the locking of the lotus edge valve, st elevation was observed on the electrocardiogram(ecg).At the same time, a decrease in the patients blood pressure was noticed.A transthoracic echocardiogram(tte) was performed and indicated the right ventricle was not moving.The 23mm lotus edge valve was resheathed and removed in accordance with the ifu.Imaging was performed in the right coronary artery (rca) and left coronary artery(lca) and blood flow was able to be confirmed without any stenosis.Function of the right ventricle recovered.Vasopressors were administered, and the patients blood pressure gradually increased.At this time, severe aortic regurgitation (ar) was noted under echocardiogram.The physician determined that it would be dangerous to continue the procedure, so the procedure was discontinued.The patient was scheduled to undergo surgical aortic valve replacement three days later.
 
Manufacturer Narrative
Device evaluated by manufacturer: the lotus edge device was returned for evaluation.The device was returned unsheathed inside the sterilization bottle.No visible issues were noted with the valve.The outer sheath, multi-lumen extrusion and guidewire ports were flushed with saline.The valve was locked on the bench without issue.A tracking model with a 23mm annulus was prepared.The device was loaded onto a safari wire.The catheter was advanced and unsheathed in a high placement, 1-2mm below the annulus.Asymmetrical unsheathing was observed.A partial resheath was performed and the device was unsheathed in a lower position, 8-10mm below the annulus with tension applied to the catheter.Asymmetrical unsheathing was observed.A partial resheath was performed and the valve was unsheathed in a lower placement again, 15mm below the annulus.No asymmetry was noted.A partial resheath was performed and the device was unsheathed at 12mm below the annulus.No asymmetrical unsheathing was noted.The device was locked and deployed in this position.
 
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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 Key10835707
MDR Text Key216102969
Report Number2134265-2020-15623
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
PMA/PMN Number
P180029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2021
Device Model Number10394
Device Catalogue Number10394
Device Lot Number0025004441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Date Manufacturer Received11/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number92630745-FA
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight59
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