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

Model Number	PV-18-40-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the 18x40 became stuck and bunched/damaged in the middle of the microcatheter.It was noted that th e catheter was damaged in the proximal end.A second coil 20x50 was used which would not detach manually.3 detachment attempts were made with the instant detacher, and only one instant detacher was used.The patient was undergoing treatment of an unruptured, saccular splenic aneurysm with a max diameter of 25mm.The patient's blood flow was normal and vessel tortuosity was moderate.The devices were prepared as indicated per the ifu.There were no related patient symptoms.

• 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: 11144581
• Report Number: 2029214-2021-00035
• Device Sequence Number: 14382546
• Product Code: KRD
• UDI-Device Identifier: 00847536033863
• UDI-Public: 00847536033863
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2021

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: 04/17/2023
• Device Model Number: PV-18-40-3D
• Device Catalogue Number: PV-18-40-3D
• Device Lot Number: B010754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2020
• Initial Report FDA Received Date: 01/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1