MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-4-8-HELIX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil was returned for analysis.The concerto pusher actuator interface (ai) was found intact.The concerto pusher was found bent at ~3.3cm from the proximal end and bent ~137.9cm, 136.5cm and 18.3cm from the distal end.The concerto pusher was found broken at the hypotube break indicator (hbi) with the release wire pulled and broken.The concerto implant coil found detached from the pusher.The implant coil was not returned.The concerto pusher shield coil was found intact.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink/damage¿ was confirmed as several bends were found with the returned concerto pusher.However, the cause for the bent pusher could not be determined.Regarding the detachment of the implant coil, it is likely the breaking of the pusher and subsequent pulling of the release wire caused the implant coil to detach.However, the cause for the pusher break and implant coil detachment could not be determined as this issue was not reported by the customer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the end of the coil wire was bent.Additional information received reported there was damage noticed upon opening the package, and preparation was performed prior to the damage being seen.There were no issues that resulted in the damage that was found.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12200645
• Report Number: 2029214-2021-00891
• Device Sequence Number: 3509492
• Product Code: KRD
• UDI-Device Identifier: 00847536033535
• UDI-Public: 00847536033535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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 Expiration Date: 10/12/2023
• Device Model Number: NV-4-8-HELIX
• Device Catalogue Number: NV-4-8-HELIX
• Device Lot Number: B100350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1