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

Model Number	H749LVSUS250
Medical Device Problem Code	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 catheter kink occurred.The patient with mild-moderate calcium was selected for a 25mm lotus edge valve implant.During advancement of the lotus edge valve delivery system, there was difficulty managing the radiopaque marker.The physician pulled the lotus edge valve delivery system back and then rotated the catheter while pushing forward, in order to have the radiopaque marker on the outer curve of the anatomy.The radiopaque marker was not on the outer curve of the anatomy.The lotus edge valve delivery system catheter kinked on the outer sheath of the catheter near the locking mechanism.The lotus edge valve delivery system was removed and exchanged for another 25mm lotus edge valve system.The new 25mm lotus edge valve system was advanced.The 25mm lotus edge valve was implanted without incident.There were no reported patient consequences.
Additional Manufacturer Narrative
Device eval by manufacturer: a lotus edge valve system was returned to boston scientific (bsc) and analyzed by a bsc quality engineer.The lotus edge valve system was returned fully sheathed.A kink was noted on the outer sheath (os) 7cm proximal to the distal tip of the os.The lotus edge delivery system was returned in the starting position.The lotus edge valve was unsheathed, locked and released without issue.No issues were noted with the lotus edge valve components.
Event or Problem Description
It was reported that a delivery system catheter kink occurred.The patient with mild-moderate calcium was selected for a 25mm lotus edge valve implant.During advancement of the lotus edge valve delivery system, there was difficulty managing the radiopaque marker.The physician pulled the lotus edge valve delivery system back and then rotated the catheter while pushing forward, in order to have the radiopaque marker on the outer curve of the anatomy.The radiopaque marker was not on the outer curve of the anatomy.The lotus edge valve delivery system catheter kinked on the outer sheath of the catheter near the locking mechanism.The lotus edge valve delivery system was removed and exchanged for another 25mm lotus edge valve system.The new 25mm lotus edge valve system was advanced.The 25mm lotus edge valve was implanted without incident.There were no reported patient consequences.

• 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: 10906258
• Report Number: 2134265-2020-16360
• Device Sequence Number: 3217549
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/06/2021

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: 08/01/2021
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025793236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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: 74 YR