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

Model Number	PV-3-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto implant coil was returned for analysis.The concerto implant coil was returned without the introducer sheath; therefore, any contributing factors could not be assessed.The concerto coil pushwire was found to be bent at ~5.0cm, kinked at ~15.0cm, at ~46.5cm, at ~83.0cm, bent at ~104.0cm and kinked at ~126.0cm from proximal end.The implant coil was found to be broken and not returned.Testing/analysis (including sem reports): the concerto coil tip od (outer diameter) was unable to be measured as it was broken and not returned.The id (inner diameter) of the introducer sheath was unable to be measured as it was not returned.No other anomalies were observed.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed as the implant coil was broken and introducer sheath were not returned.The root cause could not be determined.There were no reported issues pushing the concerto coil out from within its introducer sheath during preparation.Therefore, it is possible that the implant coil became damaged during return of the implant coil back into the introducer sheath.It is possible insufficient preparation of the concerto coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the coil would not move into the microcatheter from the introducer sheath.The patient was undergoing surgery for a y90 embolization.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.

• 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: 11882332
• Report Number: 2029214-2021-00617
• Device Sequence Number: 13780491
• Product Code: KRD
• UDI-Device Identifier: 00847536033740
• UDI-Public: 00847536033740
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/25/2021

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: 07/21/2023
• Device Model Number: PV-3-8-3D
• Device Catalogue Number: PV-3-8-3D
• Device Lot Number: B057693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR