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

Model Number	H749LVSUS270
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a delivery system kink occurred.A 27mm lotus edge valve was selected for a transcatheter aortic valve replacement (tavr) procedure.An isleeve introducer sheath was placed.A 27mm lotus edge valve was advanced and difficulty was encountered.A kink in the lotus edge valve delivery system was observed when advancing up the aorta before the arch.The lotus edge valve was removed and replaced with another valve.The procedure was completed successfully without incident.The patient is doing well.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the 27mm lotus edge was returned fully sheathed inside the sterilization bottle.The nosecone was over- seated.The release collar was noted to be in the starting position.Multiple severe kinks were noted to the distal section of the outer sheath.The kinks were on both the inner and outer curvature of the outer sheath.Due to the outer sheath damage, it was not possible to advance the device through an introducer sheath.The outer sheath, multi-lumen extrusion and guidewire ports were each flushed with 15ml saline before the device was unsheathed.The valve was locked and released without issue.
Event or Problem Description
It was reported that a delivery system kink occurred.A 27mm lotus edge valve was selected for a transcatheter aortic valve replacement (tavr) procedure.An isleeve introducer sheath was placed.A 27mm lotus edge valve was advanced and difficulty was encountered.A kink in the lotus edge valve delivery system was observed when advancing up the aorta before the arch.The lotus edge valve was removed and replaced with another valve.The procedure was completed successfully without incident.The patient is doing well.

• 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: 10897431
• Report Number: 2134265-2020-16313
• Device Sequence Number: 16833774
• Product Code: NPT
• UDI-Device Identifier: 08714729960928
• UDI-Public: 08714729960928
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/11/2020

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: 08/11/2021
• Device Model Number: H749LVSUS270
• Device Catalogue Number: H749LVSUS270
• Device Lot Number: 0025833986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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
• Patient Age: 81 YR