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

Model Number	PV-16-40-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coil has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the concerto failed to detach.The patient was undergoing treatment of an unruptured, aortic aneurysm.The max diameter was 35 mm with a 10mm neck.The anatomy was moderate in tortuosity and the blood flow was normal.The reported device and any accessory devices were prepared as indicated in the ifu.During the procedure, multiple coils were placed.A concerto coil was then attempted.At detachment, the coil did not detach after two attempts with an instant detacher and one attempt using the manual method.The coil was removed.The procedure was continued.There were no reports of patient injury.

• 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: 8506587
• Report Number: 2029214-2019-00340
• Device Sequence Number: 16198750
• Product Code: KRD
• UDI-Device Identifier: 00847536017078
• UDI-Public: 00847536017078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/11/2019

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: 12/16/2021
• Device Model Number: PV-16-40-HELIX
• Device Lot Number: A756684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1