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

Model Number	NV-2-8-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
The concerto pushwire was found broken between the positive load indicator and the break indicator with the release wire also broken.The proximal segment (including the actuator interface, part of the coupler tube, and positive load indicator) was not returned for analysis.The concerto pushwire was found to be bent in the introducer sheath at ~143.0cm from the proximal end of the pushwire.The concerto coil was found to be inverted within the introducer sheath with the wavelock at the distal end.No damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the implant coil.The concerto implant coil could not be pushed out from within the introducer sheath as resistance was encountered.The concerto implant coil tip od (outer diameter) was measured and found to be 0.0112¿ which is within specification (specification: 0.0112¿ +.001/-.002).The introducer sheath id (inner diameter) was measured and found to be 0.0185¿ (0.4699mm) which is within specification (specification: 0.47mm +0.03/-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¿ was confirmed.There were no reported issues pushing the concerto implant coil from within the introducer sheath during preparation per ifu.Therefore, it is likely the resistance occurred after hydration/inspection.The concerto implant coil was found to be inverted within the introducer sheath.It is likely that resistance would occur when attempting to push the implant coil out from this portion of the introducer sheath as this portion of the introducer sheath is designed to create resistance with the pushwire portion of the concerto coil.It is likely that the customer inadvertently inverted the concerto coil following hydration or inspection.Advancing the coil against resistance would result in the pusher to become bent.It is also possible damage occurred during return shipment to medtronic for analysis as the device came back without its protective dispenser coil.A break was found on the pushwire between the break indicator and positive load indicator; however, the cause of the break could not be determined.The release wire and coin were not retracted.There is no malfunction of the device or non-conformance to specifications that would contribute to the ¿coil resistance/stuck in sheath¿.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: 9130315
• Report Number: 2029214-2019-00956
• Device Sequence Number: 11328343
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: 00847536013346
• 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: 10/22/2021
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: A728591
• 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