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 Codes	Inadequacy of Device Shape and/or Size (1583); 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	06/09/2025
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 when the doctor put the sheath into the hub of the truselect microcatheter, the concerto coil came out and immediately formed a coil mesh.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There was no patient involvement.
Additional Manufacturer Narrative
H3: device received, analysis is progress.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 clarified that the coil "immediately formed a coil mesh" was not referring to premature detachment, and was referring to inserting into the microcatheter hub.The cause was not determined.The coil did not come out of the introducer sheath smoothly.A continuous saline flush administered and maintained as indicated in the ifu.There was no kink/damage observed to the coil or catheter.The catheter was not a medtronic product.The procedure was completed by replacing it with a new coil.The issue did not occur in the patient's body.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, a dispenser coil, and within an introducer sheath.No microcatheter was returned.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The concerto implant coil pushwire was found to be bent within the introducer sheath at ~14.9cm from distal end.The concerto implant coil appeared to be stretched and damaged within the introducer sheath.In addition, the polypropylene filament was found to be intact with the detachable element.Testing/analysis (including sem reports): during testing, the concerto implant coil failed to advance outside of the introducer sheath.In addition, no further testing was performed due to the damaged condition of the implant coil.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub ¿was unable to be confirmed, as no microcatheter was returned for further assessment; however, the event could not be ruled out.The damage found to the concerto implant coil was found to be consistent with the reported microcatheter resistance.The only detailed information provided about the microcatheter was that ¿the device was a non-medtronic device (truselect microcatheter)¿; therefore, only compatibility to be determined.The concerto coil was found to be compatible with the truselect microcatheter as the minimal inner diameter of the catheter calls for 0.021"-(via an online source) and the concerto device recommended minimal microcatheter compatibility (in) is 0.0165¿.A few possible causes for coil resistance are but not limited to, incompatible catheter, damage during preparation, user advances coil against resistance, damage to coil due to excessive tightening of rhv, and catheter hub transition; however, the root cause for the ¿coil resistance¿ was unable to be determined.The customer¿s report of ¿coil shape-poor shape outside sheath¿ was confirmed.A possible cause for ¿coil shape-poor shape outside sheath¿ is implant coil damage.It is likely the reported failure was caused by the damaged implant coil.However, the root cause could not be determined.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: 22214575
• Report Number: 2029214-2025-01390
• Device Sequence Number: 20987602
• Product Code: KRD
• UDI-Device Identifier: 00847536045071
• UDI-Public: (01)00847536045071(17)270823(10)B795812
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 08/21/2025

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-2-2-3D
• Device Catalogue Number: PV-2-2-3D
• Device Lot Number: B795812
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/28/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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