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

Model Number	PV-20-50-HELIX
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a concerto coil encountered resistance and was stuck in the proximal section of the catheter.It was reported that during aneurysm embolization, the coil expanded on its own.The implant coil pushed smoothly out from the introducer sheath.The catheter was not damaged and it was unknown if the coil was damaged.No patient symptoms or complications were associated with this event.Ancillary devices include a direxion 14 microcatheter.Additional information was received that the procedure was completed by using another one.It was clarified that the "coil expanded on it's own" meant the coil detached itself.There were no causes or contributing factors for the resistance/expanding.A continuous saline flush was administered and maintained as indicated in the ifu.There were no issues that resulted in the expanding that was found.
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.
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
Additional information was received that clarified that clarified that the coil detached prematurely and therefore, manual removal was not possible because it detached on its own.
Additional Manufacturer Narrative
B5 updated with additional information received.H6 device and eval method coding updated due to 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 that manual detachment had been attempted prior to the premature detachment.There was no damage observed to the concerto pushwire.The coil was not implanted at the intended location; it was removed from the patient with no additional intervention required.

• 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: 24559503
• Report Number: 2029214-2026-00400
• Device Sequence Number: 13094143
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: (01)00847536045064(17)280711(10)D055749
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: D055749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/10/2026; 03/19/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/17/2026; 03/30/2026
• Date Device Manufactured: 08/05/2025
• 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