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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description.As received, found that implant coil detached from the pushwire and missing.This condition was not reported initially.The concerto coil pushwire was found to bent and broken at load indicator.The coin was found no to be located against the lumen stop, and the shield coil was found to be present.No other anomalies were observed.Based on the device returned analysis and reported information we were unable to determined the cause of implant coil detach from the pushwire.Without returned implant coil any contributing factors for detachment could not be assessed and cause could not be determined.It is likely that the damage to the concerto implant coil pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.It is likely that the coil detachment occurred during the attempt to push/pull the coil through the micro catheter against the reported resistance.*note: the concerto coil instructions for use (ifu) issues the following warning: "if the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break.Gently remove and discard both the catheter and coil".If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil did not deploy during treatment.There wasn't much information given about the issues.There were not any patient symptoms or complications associated with this event.The vessel was moderately tortuous.No patient injury was reported.The device was prepped per the ifu.Evaluation of the returned device found that the implant coil was detached and missing from the pushwire.

• 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: 8684880
• Report Number: 2029214-2019-00533
• Device Sequence Number: 19410308
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/10/2019

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: 09/05/2021
• Device Model Number: NV-2-4-HELIX
• Device Lot Number: A703493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1