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

Model Number	PV-12-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto will not be returned as it was discarded.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 a concerto coil was unable to detached during a procedure.The coil was able to be delivered through the catheter; the catheter was flushed.The coil was reported to have been attempted to be detached via manual detachment only once.There was no instant detacher used.Upon removal of the catheter, it was realized that the coil did not detach.These devices were removed, assessed and photographed.The devices were then discarded at the site.Competitor devices were used to treat the patient.The patient's anatomy and the blood flow were both normal.The access vessel was the hipogastrica (vessel diameter was 10mm).The devices were reported to have been prepared and used per the instructions for use (ifu).The catheter was flushed as stated in the ifu.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8344665
• Report Number: 2029214-2019-00121
• Device Sequence Number: 1915848
• Product Code: KRD
• UDI-Device Identifier: 00847536016941
• UDI-Public: 00847536016941
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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: 12/20/2020
• Device Model Number: PV-12-30-HELIX
• Device Lot Number: A574355
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1