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); Difficult to Remove (1528); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to re-sheath the delivery system occurred.A patient was selected for a 25 mm lotus edge valve implant.During the procedure, the nosecone would not fully re-sheath back into the delivery system after the valve was released.In addition, the handle would not rotate any further.There were no patient consequences, the patient is okay.
Event or Problem Description
It was reported that failure to re-sheath the delivery system occurred.A patient was selected for a 25 mm lotus edge valve implant.During the procedure, the nosecone would not fully re-sheath back into the delivery system after the valve was released.In addition, the handle would not rotate any further.There were no patient consequences, the patient is okay.
Additional Manufacturer Narrative
H3:device eval by manufacturer: the lotus edge valve device was returned and analyzed by a boston scientific quality engineer.The device was returned partially sheathed with the release door open.No kinks or damages were observed along the length of the device.Exiting from the outer sheath was approximately 2.5 cm of the nosecone and nosecone extension.An attempt to fully re-sheath the nosecone noted that the handle could turn before it eventually jammed.No 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 any damage to the force limiter ear.Examinations of the handling housing identified that the force limiter inner carriage ears were not aligned in the handle housing rails.Further analysis identified that the rail on the right-hand handle housing was broken approximately 7cm distal from the lead screw bearing.This break would have resulted in the force limiter inner carriage ears popping out of the linear rail and not feeding into the lost motion barrel during re-sheath.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.No issues were identified with the actual handle components which could have contributed to the break.The damage to the handle components is consistent with the operator attempting to re-sheath too early.As a result, a break occurred in the release collar circumferential rail.For this type of break to occur it would have also lead to increased torsional force on the ears of the force limiter inner carriage which in turn exerted increased force on the rail section of the right-hand housing.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: 10553465
• Report Number: 2134265-2020-12789
• Device Sequence Number: 11549897
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 09/09/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0024893700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1