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

Model Number	PV-6-20-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 received a report that there was a failure to release the spring at the time of surgery.The device was removed from the patient and a new spring was installed.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.It was noted the patient's blood flow was normal and vessel tortuosity was normal.No medical or surgical intervention was needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.There was no injury as a result of the event.
Additional Manufacturer Narrative
B5 updated with additional information received.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 non-detachment was not determined; it was only noted the coil did not detach from the device.Two attempts were made to detach the coil manually; an instant detacher was not used during the procedure.There were no issue encountered during the procedure prior to the non-detachment.No damage was observed on the pushwire after removal.
Additional Manufacturer Narrative
Product analysis as found condition- the concerto device was returned for analysis within a shipping box, within an opened concerto outer carton, within a resealable plastic pouch and within a dispenser coil.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found unbroken.There were no evidence of detachment attempts at these locations using an instant detacher or by manual method.The pusher was found kinked at ~37.4cm (figure e) from the proximal end and found kinked between ~13.0cm and ~8.5cm (figure f) from the distal end.The coin was found still against the lumen stop.The detach element was found still attached to the pusher (figure g).The concerto implant was found separated/broken from the detach element at the coil shell (figure g).The implant coil was found severely stretched within and outside the introducer sheath with the polypropylene filament broken (figure i).Large amount of blood was found within the introducer sheath.Testing/analysis a detachment was attempted by breaking the break indicator and retracting the exposed release wire and the release wire was found stuck within the pusher.The outer jacket was removed from distal to the kinks and the release wire was retracted from that location, detaching the detach element 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 detach element still attached.Customer had reported attempting two manual detachment attempts.However, no breaks were found throughout the length of the pusher.One likely contributor of the non-detachment is the kinks on the pusher, causing the release wire to become stuck.The device was successfully detached by retracting the release wire distal to the kinks.Possible causes for pusher kinking are advancing coil against resistance 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: 22170367
• Report Number: 2029214-2025-01338
• Device Sequence Number: 20788059
• Product Code: KRD
• UDI-Device Identifier: 00847536045163
• UDI-Public: (01)00847536045163(17)261123(10)B676129
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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-6-20-3D
• Device Catalogue Number: PV-6-20-3D
• Device Lot Number: B676129
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 06/11/2025; 10/03/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/30/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2024
• 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: Male