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	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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
Medtronic reported that during a neurovascular procedure involving the concerto coil, the physician was unable to detach the coil using the instant detacher, despite three attempts.A manual detachment attempt via hypotube was also made once, but was unsuccessful.The same instant detacher was later used successfully to detach subsequent coils.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a terumo sheath and rebar18 microcatheter.
Additional Manufacturer Narrative
B5 updated with additional information received.H3.Device was returned.Completion of analysis is pending.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 received reported the cause of the coil non-detachment could not be determined.There were no issues encountered prior to the non-detachment.There was no pushwire damage observed after the coil was removed.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- vis m-81805 203 cm ruler m-83361 as found condition- the concerto device was returned for analysis within a shipping box, within an opened concerto outer carton, and within an opened concerto inner pouch.No introducer sheath was returned.Visual inspection/damage location details - the actuator interface was found securely attached to the coupler tube.No evidence of detachment attempts was found at this location with an instant detacher.The concerto pusher was found kinked, but unbroken, at the break indicator at 4.8cm from the distal end, indicative of an incomplete manual detachment attempt.The concerto pusher was found bent at 146.1cm from the proximal end.The coin was found undamaged and against the lumen stop.The shield coil was found to be damaged.The implant coil was already detached and not returned for analysis.The lumen stop was found undamaged.Testing/analysis ¿ the release wire was retracted against resistance and found to be covered in blood.The coin was measured to be ~0.074mm @ 0.063mm, ~0.087mm @ 0.127mm, and ~0.097mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm) (figure i).The lumen stop inner diameter was measured to be 0.00272¿, which is still within specification (specification: 0.00220¿ ¿ 0.0029¿).Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the concerto was returned with the implant already detached and not returned.However, the event could not be ruled out.There was no p ushwire damage observed after the coil was removed.¿.Possible causes for the ¿non-detachment¿ are, but not limited to, damaged pusher, coil shield wrapped around coil shell or proximal end of implant coil, and blood under the shrink tubing at the detachment zone.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Additional information received reported that ¿the cause of the coil non-detachment could not be determined.There was no pushwire damage observed after the coil was removed.The pusher was found kinked (not broken) at the break indicator; therefore, unable to confirm the manual detachment reported by the customer.The report states that ¿the physician was unable to detach the coil using the instant detacher, despite three attempts.¿.This was unable to be confirmed as the actuator interface was found to be intact with no irregularities.The likely cause could not be determined.As the implant coil and instant detacher were not returned for analysis, any contribution of the implant and instant detacher towards the reported non-detachment could not be assessed.During testing, the pusher was found to have blood under the ptfe shrink tubing, on the release wire and within the lumen stop.It is possible the blood contributed towards the non-detachment.H6.Coding updated based on analysis findings.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: 21961633
• Report Number: 2029214-2025-01121
• Device Sequence Number: 7265737
• Product Code: KRD
• UDI-Device Identifier: 00847536045125
• UDI-Public: (01)00847536045125(17)270903(10)B796221
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/02/2025

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-3-8-3D
• Device Catalogue Number: PV-3-8-3D
• Device Lot Number: B796221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 06/07/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/14/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Patient Sex: Unknown