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

Model Number	PV-18-40-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
The concerto pushwire was found broken in three locations.The first break was at the positive load indicator with the release wire was also found broken.The second break was found between the positive load indicator and break indicator and retained by the release wire.The third break was found distal to the break indicator at the coupler tube/hypotube junction also retained by the release wire.This is indicative that manual detachment was attempted at these locations.Bends and kinks were found between the positive load indictor and break indicator, and at ~30.2cm, ~36.8cm, and ~141.4cm from the proximal end of the most distal segment.The coin was found pulled back from the lumen stop and the shield coil was present but damaged.The implant coil was already detached and not returned for analysis.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 root cause could not be determined.The concerto coil could not be used for resistance testing with an in-house micro catheter as the implant coil was already detached.There was evidence of detachment attempts, and the coin was pulled back from the lumen stop, releasing the implant coil as intended.Bends and kinks were found throughout the length of the pushwire, however, the cause could not be determined.Potential causes are user advancing the coil against resistance or damaged during return shipping to medtronic for analysis as the device was returned without its protective dispenser coil and introducer sheath.The shield coil was found damaged; however, the cause could not be determined.It is possible the shield coil became damaged when attempted to advance the coil against resistance or during return shipping to medtronic.Since the micro catheter used in the event was not returned, and the model or lot number was not provided, any contribution of the micro catheter towards the reported ¿coil resistance/stuck in catheter¿ could not be assessed.There was no indication that the event was related to a manufacturing issue, therefore a device history review is not required.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the concerto coil encountered resistance within the catheter.The coil was noted to have been damaged.It is unknown if the devices were used per the instructions for use (ifu).No other information is available.The model and lot number of the microcatheter that was used is unavailable.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9164962
• Report Number: 2029214-2019-00996
• Device Sequence Number: 3643559
• Product Code: KRD
• UDI-Device Identifier: 00847536017108
• UDI-Public: 00847536017108
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 04/02/2022
• Device Model Number: PV-18-40-HELIX
• Device Catalogue Number: PV-18-40-HELIX
• Device Lot Number: A809662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1