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

Model Number H749LVSUS250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Exemption number: e2020001.Quarterly reporting period: q4 2020.Average time to event: 0 days.Device evaluation: under the terms and conditions of the registry, anonymized data was provided.It cannot be determined if these events have been previously reported or if the devices were returned for analysis.However, the events reported were anticipated in nature as defined by the potential adverse events list in the fda-approved instructions for use (ifu).

Event Description

This report summarizes 1 serious injury event for blood loss.Boston scientific received notification of events for the lotus edge valve reported in the sts/acc tvt registry.The data is collected in order to monitor patient safety and real-world outcomes related to transcatheter valve replacement and repair procedures.Patient events were reported as event terms with no further detailed information.Under the terms and conditions of the tvt registry, data is anonymized before being transmitted to bsc, thus there are significant limitations to bsc's ability to correlate the data to information previously reported.The events are most likely duplicates with potential for non-device related adverse events included.No further information is available to bsc.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; maple grove MN
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11170211
• MDR Text Key: 226801017
• Report Number: 2134265-2021-00202
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: H749LVSUS250
• Device Catalogue Number: H749LVSUS250
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 93