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

Model Number	PV-2-2-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 product analysis: as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, an opened concerto outer (b801365) carton, an opened concerto inner pouch (b801365), a resealable plastic bag, and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: no introducer sheath was returned.The pushwire was found to be bent at ~6.1m, damaged (twisted) at ~153.6cm, and damaged distal to the detach element from the proximal end.The concerto implant coil was found to be broken off and not returned.The detach element was found to be still intact with the pushwire.The shield coil was found to be damaged.The coin was found to be retracted from the lumen stop.No other anomalies were observed.Testing/analysis (including sem reports): none.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was able to be confirmed, as the concerto device was returned with the pushwire bent, damaged, and the implant coil broken off and not returned.The damage found with the concerto device was found to be consistent with advancement against resistance.No implant coil was returned for assessment; therefore, any contribution the implant coil had towards the resistance/break was unable to be assessed.A few possible cause of catheter resistance are but not limited to, incompatible catheter, damage or kink to pushwire, and/or user does not maintain continuous flush; however, the root cause was unable to be determined.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed.No introducer sheath was returned for assessment.Any contribution the introducer sheath had towards the resistance/break was unable to be assessed.The report notes that ¿concerto coil had resistance/was stuck in the sheath.Furthermore, it was reported that the coil became entangled with the microcatheter and damaged it.¿.The non-medtronic (prograde 2.4 fr) microcatheter mentioned in the procedure was not retur ned; therefore, the condition of the catheter was unable to be assessed.Any contribution the catheter had towards the damage/resistance was unable to be verified.Compatibility cannot be confirmed as no lot or reference numbers were provided for the non-medtronic catheter.It was reported that the concerto coil was prepared; although, during preparation, the introducer sheath was not held vertically when the implant coil was pulled back inside during hydration; the device was held horizontally.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 report regarding concerto coil that had resistance/was stuck in the sheath.Furthermore, it was reported that the coil became entangled with the microcatheter and damaged it.There were no patient symptoms or complications associated with this event.(b)(6) 2026 e1 (rep, hcp, for): additional information received reported that during preparation, the introducer sheath was not held vertically when the implant coil was pulled back inside during hydration; the device was held horizontally.The coil never entered the microcatheter or the patient's body.The coil was replaced to complete the procedure successfully.Ancillary device: terumo progreat 2.4f catheter.

• 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: 24618934
• Report Number: 2029214-2026-00452
• Device Sequence Number: 9833801
• Product Code: KRD
• UDI-Device Identifier: 00847536045071
• UDI-Public: (01)00847536045071(17)270903(10)B801365
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 03/17/2026

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-2-2-3D
• Device Catalogue Number: PV-2-2-3D
• Device Lot Number: B801365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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