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

Model Number	H749LVSUS230
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery system kinked.A 23mm lotus edge valve was selected for implant.During the procedure, the lotus edge valve delivery system kinked when exiting the isleeve introducer in the descending aorta.The device was removed and new 23mm lotus edge valve was prepped and implanted without incident.There were no patient consequences reported.
Additional Manufacturer Narrative
The lotus edge valve and delivery system were received for analysis.The lotus edge valve and delivery system were returned fully sheathed with the nosecone over-seated.A kink was noted to the outer sheath on the outer curve of the delivery system at 6.3cm proximal from the tip of the outer sheath.The multi-lumen extrusion, outer sheath and guidewire ports were each flushed with 15ml saline before the valve was unsheathed.No issues were noted with the valve components and the valve was successfully locked and released using the handle mechanism.No other issues were noted during device analysis.Procedural angiographic media was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.During the recording of the case, the lotus edge valve delivery system is advanced into an isleeve introducer sheath, maintaining the s-shape on the catheter.The operator wets the catheter as it is advanced, while the isleeve introducer sheath is continuously flushed.The lotus edge valve delivery system is observed in the descending aorta after exiting the isleeve introducer sheath.The physician rotates the delivery system to place the radiopaque marker on the outer most curvature of the anatomy, however, it is noted that the outer sheath is kinked.The device is successfully withdrawn.The remaining minutes of the live case show the successful completion of the procedure with a second lotus edge valve.
Event or Problem Description
It was reported that the delivery system kinked.A 23mm lotus edge valve was selected for implant.During the procedure, the lotus edge valve delivery system kinked when exiting the isleeve introducer in the descending aorta.The device was removed and new 23mm lotus edge valve was prepped and implanted without incident.There were no patient consequences reported.

• 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: 10792330
• Report Number: 2134265-2020-15321
• Device Sequence Number: 1138412
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 01/22/2021
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0025456950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/09/2020
• 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