MAUDE Adverse Event Report: Solo Pace, Inc. Solo Pace Fusion System; Guidewire

Model Number	SOLOFUSE1
Medical Device Problem Code	Intermittent Capture (1080)
Health Effect - Clinical Code	Aortic dissection (4870)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "customer reports they were completing a tavr with medtronic evolut valve.Shallow core valve and embolized on post dil.Patient did not need open surgery, they left the valve in place and placed a new evolut medtronic valve." the valve embolization resulted in a vessel dissection that was addressed through vascular surgical intervention.The patient did not require any additional treatment following the intervention, and the patient outcome was reported as good.
Additional Manufacturer Narrative
During a follow-up interview with the user, it was determined that loss of capture occurred during the procedure.Review of the procedural imaging identified that the fusion wire was positioned on top of the mitral valve apparatus where loss of contact is a known risk during valve deployment when balloon inflation shifts the relationship of the conducting part of the lead wire to the myocardium and leads to loss of contact and resultant loss of capture.A review of the epg logs did not identify any pacing or sensing issues.A review of the production records did not identify an issue with the epg or fusion components.Based on the information obtained from the customer and review of the imaging, potential contributing factors to the valve embolization included the shallow positioning of the transcatheter valve and the position of the fusion wire, which resulted in loss of capture.

• Brand Name: Solo Pace Fusion System
• Common Device Name: Guidewire
• Manufacturer (Section D): Solo Pace, Inc.; 7125 northland terrace n; brooklyn park MN 55428
• Manufacturer (Section G): Solo Pace; 7125 northland terr n; brooklyn park MN 55428
• Manufacturer Contact: straight ; 7125 northland terr n; brooklyn park, MN 55428 ; +1(612)940-7240
• MDR Report Key: 50698376
• Report Number: 3035372913-2026-00011
• Device Sequence Number: 5915365
• Product Code: DQX
• UDI-Device Identifier: 00850056280044
• UDI-Public: 00850056280044
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K252674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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 Model Number: SOLOFUSE1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown