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

Model Number H749LVSUS250

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device eval by manufacturer: the lotus edge valve device was returned to boston scientific(bsc) and analyzed by a bsc quality engineer.The lotus edge valve system was returned fully sheathed and with the safari guidewire (gw) inserted.Safari gw movement was attempted which was unsuccessful, confirming that the gw was stuck within the lotus edge device.There was approximately 115cm of the gw protruding out of the gw port.The gw was kinked 5cm proximal to the gw port.There was 2cm of the gw protruding from the tip of the nosecone and the coils appeared displaced on the exposed gw portion.The lotus edge valve was unsheathed, and the nosecone extension (nce) appeared undamaged.The lotus edge valve was released and there was no damage noted on the nce.The gw was removed from the lotus edge valve delivery system after lotus edge valve deployment.Approximately 12cm of the distal gw coils became displaced during removal.

Event Description

It was reported that the lotus edge valve delivery system froze on the guidewire.The patient was selected for a 25mm lotus edge valve implant.A right transfemoral approach was gained.A safari2 guide wire was inserted.A 25mm lotus edge valve was advanced over the safari2 guidewire.The 25mm lotus edge valve was positioned and unsheathed.The physician assessed the position of the 25mm lotus edge valve and determined a position change was warranted.The 25mm lotus edge valve was resheathed.The x-ray imaging equipment went down resulting in the loss of fluoroscopy.The x-ray imaging equipment still had video capabilities.The physician elected to remove the 25mm lotus edge valve.When the physician attempted to remove the 25mm lotus edge valve, the lotus edge valve delivery system locked up on the safari2 guide wire in the descending aorta.The lotus edge valve delivery system and safari2 guide wire were removed from the patient together as one unit.The devices were not able to be separated outside of the patient.The physicians attempted to proceed with the procedure by using a portable c-arm imaging equipment to complete the procedure; however, the imaging was substandard.The procedure was then aborted.The patient had a gradient of over 40mmhg at the start of the case, and it was reduced at the end of the procedure.The patient was discharged home and is expected to be brought back in 4-6 weeks to attempt a valve implant again.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10774727
• MDR Text Key: 214376295
• Report Number: 2134265-2020-14214
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0025952409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR