MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE; LOTUS EDGE TM VALVE SYSTEM 23 MM

Model Number	H749LVSUS250
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Arrhythmia (1721); Blood Loss (2597)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 device evaluated by manufacturer: the complaint device was returned for analysis.The device was returned with the handle in the release phase.The device was fully sheathed with the nosecone correctly seated.No valve was returned as it was implanted in the patient.The device ports were flushed with 15ml of saline solution before the device was unsheathed.No issues were noted with the distal components or the handle of the device.
Event or Problem Description
Reportable based on additional information received 13 august, 2020.It was reported that during the procedure, the 25mm lotus edge valve was difficult to lock and required multiple repositionings in order to lock.The 25mm lotus edge valve was able to be locked and deployed with a good final result.No patient complications were reported.The patient was doing fine.Additional information received reports on the date of the index procedure, minor vascular complication occurred.Four (4) days post index procedure a conduction disturbance requiring pacemaker occurred.

• Brand Name: LOTUS EDGE VALVE
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM 23 MM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10491475
• Report Number: 2134265-2020-12015
• Device Sequence Number: 2404109
• Product Code: NPT
• UDI-Device Identifier: 08714729960911
• UDI-Public: 08714729960911
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Device Lot Number: 0024014928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 09/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR