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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two concerto coil pushwires and a concerto implant coil were returned for analysis within a shipping box; within a sealed biohazard bag; within their opened concerto implant coil inner pouches and within individual dispenser tracks.The micro catheter used in the event was not returned.In addition, the model or lot number was not provided; therefore, compatibility could not be assessed.T(pushwire 1) the concerto coil was returned for evaluation without the introducer sheath.The concerto pushwire was found to be broken at proximal end.In addition, the pushwire was found to be bent at ~3.8cm and kinked at ~167.3cm from broken end.The release wire was found to be extending ~0.4cm from broken end.The implant coil was found to be detached and the coil shell was found to be stretched.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.All other subassemblies appeared to be normal and no other anomalies were observed.The concerto coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.(pushwire 2) the concerto pushwire was found to be be nt at load indicator ~ 4.2cm from proximal end.The ai (actuator interface) and coupler tube were found to be present but loose.The implant coil was found to be detached.Under the microscope, the coin was found to be present but not located against the lumen stop, and the shield coil was found to be present.Based on the received condition and product analysis the model and lot of the concerto coils could not be ascertained; therefore, it could not be determined which device allegation each concerto coil corresponds to.(implant coil 1) a detached concerto implant coil was returned.It was found to be stretched and damaged.What appeared to be dry blood residue was found on the implant coil.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed; however, the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the concerto coil prior to use, and lack of continuous flush during delivery.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that these all coil could not pass the microcatheter hub.The physician followed by the ifu.There were no adverse patient effects.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Detailed information about the patient and devices used were not available due to a hospital policy.

• 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: 8741910
• Report Number: 2029214-2019-00632
• Device Sequence Number: 16541920
• Product Code: KRD
• UDI-Device Identifier: 00847536013704
• UDI-Public: 00847536013704
• 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
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 06/29/2020
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: A485015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1