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

Model Number	NV-4-8-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No damages or irregularities were found with the introducer sheath.The concerto pushwire was found broken at the break indicator with the release wire also broken.The proximal segment (actuator interface, positive load indicator, and part of the coupler tube) was not returned for analysis.This is indicative that a manual detachment was attempted at this location.The concerto pushwire was found to be bent at ~6.0cm, ~39.1cm, ~101.6cm and ~171.9cm from the proximal end of the pushwire.The coin was found retracted from the lumen stop.The shield coil was present and slightly stretched with the implant coil already detached and not returned for analysis.The concerto implant coil tip od (outer diameter) could not be measured as it was not returned.The introducer sheath id (inner diameter) was measured and found to be 0.0190¿ (0.4826mm) which is within specification (specification: 0.47mm +0.05/-0.00).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the device was returned with the implant coil already detached.There is evidence that a manual detachment was attempted at the break indicator and the coin was retracted from the lumen stop, detaching the implant coil.The pushwire was found bent throughout the length of the pushwire, indicative of high patient tortuosity.It is also possible that damage to the pushwire occurred during return shipment to medtronic for analysis as the device came back without its protective dispenser coil.The shield coil was found stretched, however the cause could not be determined.It is possible the shield coil became damaged due to attempts to advance or retract the pushwire against the reported resistance or during return shipping to medtronic for analysis.There is no malfunction of the pushwire or non-conformance to specifications that would contribute towards ¿coil resistance/stuck in sheath¿ as the implant coil was not returned for analysis, any contribution of the implant coil towards the failure could not be determined.There is no indication that the event is related to a manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the procedure could not be performed because the coil did not enter the microcatheter while performing the procedure in accordance with the ifu.The devices were prepared as indicated in the ifu.There were no abnormalities reported in relation to the anatomy.

• 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: 9130389
• Report Number: 2029214-2019-00958
• Device Sequence Number: 11328348
• Product Code: KRD
• UDI-Device Identifier: 00847536013438
• UDI-Public: 00847536013438
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 07/07/2020
• Device Model Number: NV-4-8-HELIX
• Device Catalogue Number: NV-4-8-HELIX
• Device Lot Number: A488085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1