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

Model Number	NV-9-30-HELIX
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
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
Event reported in lieu of analysis results.Analysis of the concerto implant coil (lot no.A830915) found that the coil was returned without introducer sheath.The concerto implant pushwire was found to be kinked at ~6.1 and broken but retained by release wire at ~7.9 cm from proximal end.The concerto implant coil was found to be detached and not returned.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil-shape-loop size¿ could not be confirmed and the cause could not be determined.No defect was found with the returned concerto implant coil that would have contributed to the event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information reporting that during deployment a concerto coil was not forming loops as desired.The coil and all a ccessory devices were prepared as indicated in the instructions for use.The coil was removed and replaced with another medtronic coil that was used successfully.There was no harm or injury to the patient.

• 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: 12111888
• Report Number: 2029214-2021-00815
• Device Sequence Number: 19983556
• Product Code: KRD
• UDI-Device Identifier: 00847536013766
• UDI-Public: 00847536013766
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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: 05/13/2022
• Device Model Number: NV-9-30-HELIX
• Device Catalogue Number: NV-9-30-HELIX
• Device Lot Number: A830915
• 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: 07/01/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1