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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See manufacturer report # 2029214-2020-00683 for report the first coil.The concerto pusher (model: nv-2-4-helix lot: a839242) was returned for analysis.The concerto pusher was found broken at the break indicator with the release wire found separated from the actuator interface.The proximal segment of the pusher was not returned for analysis.The concerto pusher was found bent at 19.5cm and 83.4cm from the proximal end.The coin was found retracted out of the lumen stop with the shield coil present and intact and the implant coil already detached and not returned for analysis.No other damages or abnormalities were observed.Based on the analysis performed, the customer report of ¿non-detachment, detached with hypotube¿ could not be confirmed through analysis.There was evidence of a manual detachment by breaking the break indicator.However, since the proximal segment of the pusher was not returned, any detachment attempts using an instant detacher could not be assessed.As the implant coil was not returned, any contribution of the implant coil towards the non-detachment could not be determined.Possible causes for non-detachment are damaged pusher, coin jammed in lumen stop, intact twr crimps or detachment stick bent or out of specification.The pusher was found bent.It is possible the pusher became bent when attempting to advance the device against resistance.There was no non-conformance to specification identified that could potentially contribute towards the non-detachment.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that two concerto coils failed to detach using the instant detacher.The patient was undergoing surgery for treatment of a gi bleed.It was noted the patient's blood flow and vessel tortuosity were normal.It was reported that one of the 2x4 concerto coils would not detach with the instant detacher or manually.The second coil would not detach with the instant detacher, but it did detach manually.The instant detacher was used twice, and a second detacher was not used.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.There were no issues encountered prior to the non-detachment issue.The coils pushed out smoothly.The wire was not kinked/bent before the issues.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10659517
• Report Number: 2029214-2020-01009
• Device Sequence Number: 14340665
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: A839242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1