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

Model Number	PV-12-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the concerto coil helix 12mm x 30cm did not deploy using a detacher or manually.The coil and packaging were retained for investigation.The device was prepped per the instructions for use with no issues identified.There was said to be no patient involved.
Additional Manufacturer Narrative
Continuation of d10: product id id-1-5 (lot: unknown); implant date n/a; explant date n/a.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
G3: initial report aware date was noted to be 18-mar-2025.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received that the event occurred on 28-feb-2025.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition- the concerto device was returned for analysis within a shipping box; within a sealed tyvek biohazard pouch; within an opened concerto inner pouch and without its protective dispenser coil or introducer sheath.Visual inspection/damage location details: the concerto pusher was found broken at the actuator interface and at the break indicator.The release wire was found broken/separated from the actuator interface and extending out of the proximal end of the distal pusher segment.The pusher was found twisted and flattened at ~35.0cm from the distal end.The coin was found present and still against the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found damaged.Testing/analysis ¿a detachment was attempted by retracting the exposed release wire and the release wire was found stuck within the pusher.The ptfe shrink jacket was removed distal to the twisted/flattened section and the release wire was retracted from that location, detaching the implant coil with no issues and no resistance encountered.No other damages or anomalies were found with the returned device.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the device was returned with the implant coil still attached.The likely cause of the non-detachment is the damages found on the pusher, causing the release wire to become stuck within.The device was successfully detached by retracting the release wire distal to the flattened/twisted section.Possible causes for pusher kinking are advancing coil against resistance, pusher rotation, or damage during preparation.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21679562
• Report Number: 2029214-2025-00754
• Device Sequence Number: 7599907
• Product Code: KRD
• UDI-Device Identifier: 00847536045002
• UDI-Public: 00847536045002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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 Model Number: PV-12-30-HELIX
• Device Catalogue Number: PV-12-30-HELIX
• Device Lot Number: D007165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 05/08/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/03/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown