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

Model Number	H749LVSUS250
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system failed to re-sheath.Access was gained through a right transfemoral approach.Balloon aortic valvuloplasty(bav) was performed with a 20mm non-boston scientific(bsc) balloon.A 25mm lotus edge valve system was implanted.After the lotus edge valve was deployed successfully, the physician attempted to turn the control knob to re-sheath the lotus edge valve delivery system sheathing aids, but the handle would not rotate.The lotus edge valve delivery system was then removed with the sheathing aids exposed.There were no patient consequences.
Event or Problem Description
It was reported that the handle failed to rotate and the delivery system failed to re-sheath.A 25mm lotus edge valve implant was implanted during a transcatheter aortic valve replacement (tavr) procedure.Of note, the handle knob was turned to hard stop before the release phase, and the release knob was turned to hard stop before recapturing.After the lotus edge valve was deployed successfully, the physician attempted to turn the blue knob on the lotus edge valve delivery system to capture the nosecone, but the handle would not rotate.The lotus edge valve delivery system was then removed with the sheathing aids exposed; it was removed from the patient separate from the introducer sheath.There were no patient consequences.
Additional Manufacturer Narrative
H3 device evaluated by mfr: the lotus edge device was returned fully sheathed with the release door open.No kinks or damages were observed along the length of the device.The device was then unsheathed with some stiffness noted when unsheathing the sheathing aids.The device was unable to unsheath to lost motion due to the push pull rods being stuck.No taut/tension was noted on the outer sheath.The blue control knob was removed and no damage was noted to the ring gears.Damage was visible to the release collar circumferential rail.This was consistent with the force limiter ear driving through the circumferential rail.There did not appear to be any damage to the force limiter ear.Examinations of the handling housing found no damage to the linear rail.The mis-alignment of the force limiter inner carriage ears and the lost motion barrel lead to a jam up of the handle which confirms the complaint incident.The damage to the handle components are consistent with the operator attempting to re-sheath too early.As a result, a break occurred in the release collar circumferential rail.The damage is consistent with the user not rotating back from hard-stop with the release collar.This would have put a lot of force on the inner carriage which likely resulted in the break in the right-hand housing rail which unseated the inner carriage.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10780676
• Report Number: 2134265-2020-14892
• Device Sequence Number: 1126824
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P180029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025688275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92630745-FA
• Patient Sequence Number: 1