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

Model Number	NV-3-8-HELIX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description.The device was returned and found the concerto implant coil was found to be broken and damaged.This was not reported at the time of event.Additionally, the concerto implant coil pushwire was found to bent at load indicator.The detach element was found to be broken.The coin was found to be located jammed against the lumen stop, and the shield coil was found to be present.Based on the device analysis we were unable to determine the cause of implant coil "broke" from the pushwire.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.Per instructions for use (ifu): precautions: ¿do not advance the coil with force if the coil becomes lodged within or outside the micro catheter.Determine the cause of resistance and remove the system when necessary." related mdr for this event: 2029214-2019-00251.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report of concerto coil that stuck inside the catheter during deployment.The patient was undergoing coiling of a gi bleed.The patient anatomy was normal.It was reported that during placement, half of the coil was out of the microcatheter into the patient and the other half was still in the microcatheter.The coil reportedly became locked and could not be advanced.The coil was removed from the patient.The microcatheter was flushed.The same coil was attempted to be used but could not enter the hub.No patient injury was reported.Evaluation of the returned device found that the implant coil was broke 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: 8672366
• Report Number: 2029214-2019-00519
• Device Sequence Number: 10835652
• Product Code: KRD
• UDI-Device Identifier: 00847536013391
• UDI-Public: 00847536013391
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/05/2019

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: 01/24/2022
• Device Model Number: NV-3-8-HELIX
• Device Lot Number: A772224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR