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

Model Number	PV-20-50-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is being reported at this time based on analysis results.Product analysis: the concerto pusher actuator interface (ai) was found loose, and the pusher coupler tube was found detached at the tack welds.These damages indicate that there may have been an attempt to detach the implant coil using an instant detacher (id).The pusher segments were retained by the release wire, which was pulled for ~30.0 cm.The distal end of the pusher was found bent, and the implant coil was found detached.The pusher release wire coin was pulled back from the lumen stop, and the shield coil was damaged.The implant coil was not returned.Based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in catheter¿ report could not be confirmed, and the cause could not be determined.Possible contributing factors to ¿coil resistance¿ include using an incompatible device for delivery, tortuous anatomy, failure to maintain a continuous flush, and failure to hydrate the concerto coil before use.However, there is insufficient information to determine possible or root causes.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the coil stuck in the catheter.The patient was undergoing surgery to treat an aneurysm with a max diameter of 20 mm.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Additional information received reported the two complaint coil for this event did push out smoothly from the introducer sheaths.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12351779
• Report Number: 2029214-2021-01048
• Device Sequence Number: 17220705
• Product Code: KRD
• UDI-Device Identifier: 00847536033689
• UDI-Public: 00847536033689
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 11/03/2023
• Device Model Number: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: B111999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1