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

Model Number	NV-10-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil (model: nv-10-30-helix lot: a738181) was returned for analysis.The terumo catheter used during the event will not be returned for analysis.In addition, the model or lot number were not provided; therefore, compatibility could not be assessed.The concerto coil was returned outside the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The concerto pushwire was found to be broken at positive load indicator and retained by release wire.The concerto implant coil was found to be broken/missing.The concerto coil could not be used for testing with an in-house microcatheter due to its damaged condition.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ could not be confirmed and the cause could not be determined.Advancing the concerto coil against resistance would result in damage to the implant coil.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, damage/kink to pushwire and lack of continuous flush during delivery.The concerto implant coil was found broken/missing.It is likely that the damage to the concerto implant coil occurred during the attempt to push the coil through the micro catheter against the reported resistance.Other possible causes for coil/pushwire damage are: lack of hydration before procedure, user does not maintain continuous flush, coil not retracted in a one-to-one motion with the implant pushwire during repositioning, pushwire rotation, or incompatible catheter.It was reported all the devices were prepared per the ifu.Since the terumo catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.As the model and lot number of the micro catheter was not reported, compatibility could not be assessed.Information regarding tortuous patient anatomy was not provided.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the concerto coil was stuck inside the microcatheter.The product was replaced by another medtronic product to complete the procedure.No patient injury was reported as a result of the event.It was reported the device was prepped as indicated in the instructions for use (ifu).It was unknown if the coil come out of the introducer sheath smoothly, if the coil was damaged after removal.A terumo catheter was used.

• 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: 10567638
• Report Number: 2029214-2020-00957
• Device Sequence Number: 19625028
• Product Code: KRD
• UDI-Device Identifier: 00847536013285
• UDI-Public: 00847536013285
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

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 Expiration Date: 11/08/2021
• Device Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: A738181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1