MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR CONCERTO DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-5-20-HELIX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of duodenal ulcer with acute gi bleed and hemorrhagic shock.Procedure: mesenteric arteriogram with embolization performed.Physician unable to deploy the coil correctly.New one used without further problems.No known harm to patient from this event.Manufacturer response for device, vascular, for promoting embolization, concerto detachable coil system (per site reporter), will obtain.

• 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: 19700602
• Report Number: 19700602
• Device Sequence Number: 20747139
• Product Code: KRD
• UDI-Device Identifier: 00847536044944
• UDI-Public: (01)00847536044944(17)260104(10)225707557
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/11/2024
• Report Date (Section F): 06/11/2024

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: NV-5-20-HELIX
• Device Lot Number: 225707557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 06/11/2024