MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR. Concerto Detachable Coil System; Device, Vascular, for Promoting Embolization

Model Number	PV-8-30-3D
Medical Device Problem Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor tried to deploy the concerto detachable coil system for a splenic bleed but there was too much resistance so he could not do so.No harm.

• Brand Name: Concerto Detachable Coil System
• Common Device Name: Device, Vascular, for Promoting Embolization
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 50817930
• Report Number: 50817930
• Device Sequence Number: 18694749
• Product Code: KRD
• UDI-Device Identifier: 00847536045187
• UDI-Public: (01)00847536045187(17)280228(10)D030291
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/01/2026
• Report Date (Section F): 09/01/2026

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 Model Number: PV-8-30-3D
• Device Catalogue Number: pv-8-30-3D
• Device Lot Number: D030291
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/01/2026