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

Model Number	PV-12-40-3D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 during deployment of the concerto coil, the coil became lodged in the distal end of the  microcatheter.The physician tried to pull the coil back for repositioning, but it would not move.Then an attempt at advancement was made, but the coil would not move.On the second attempt to withdraw the coil, the introducer wire came out of the microcatheter with a small piece of the coil still attached: the coil had broken.The rest of the coil was still in the microcatheter in the patient.The physician then removed the microcatheter and diagnostic catheter together which allowed for the rest of the coil to be removed without incident.It was noted there was no damage to the microcatheter, no friction or difficulty during testing or delivery up until the distal segment, a continuous flush had not been used, repositioning was performed once, the pushwire was not damaged, no detachment attempts had been made, it was unknown if the pushwire had been rotated, and no medical or surgical intervention was required.It w as indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment in the venous collateral.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include a terumo progreat 2.8f microcatheter.

• 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: 11444613
• Report Number: 2029214-2021-00270
• Device Sequence Number: 14292635
• Product Code: KRD
• UDI-Device Identifier: 00847536033832
• UDI-Public: 00847536033832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 10/09/2023
• Device Model Number: PV-12-40-3D
• Device Catalogue Number: PV-12-40-3D
• Device Lot Number: B099274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR