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

Model Number	PV-14-30-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	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported in lieu of analysis results.Analysis of the concerto coil (lot no.A592642) found that the pusher actuator interface (ai) was bent.The concerto pusher was found broken at the load indicator with the release wire pulled.The concerto pusher hypotube break indicator (hbi) was found intact.The concerto pusher was found bent at ~165.5 cm and ~34.5 cm from the distal end of the pusher.The release wire coin was found pulled back from the lumen stop, the shield coil was found in good condition, and the implant coil was detached from the pusher.The concerto implant coil was not returned.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.The concerto implant coil was not returned.Therefore, analysis could not be performed and conformance to specification could not be assessed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information reporting that a during a procedure, the concerto coil was not forming loops as expected so the device was withdrawn and replaced with a new medtronic device.It was noted that the concerto coil and all accessory devices used were prepared according to the instructions for use (ifu).There was no patient injury.

• Brand Name: CONCERTO PGLA HLX
• 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: 11898292
• Report Number: 2029214-2021-00633
• Device Sequence Number: 19160052
• Product Code: KRD
• UDI-Device Identifier: 00847536017016
• UDI-Public: 00847536017016
• 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): 05/27/2021

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: 02/04/2021
• Device Model Number: PV-14-30-HELIX
• Device Catalogue Number: PV-14-30-HELIX
• Device Lot Number: A592642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1