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

Model Number	PV-12-40-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 product analysis: ¿as found condition: the concerto coil pusher wire was returned for analysis inside a dispenser coil, inside an open concerto coil inner pouch, within a clear sealed biohazard plastic pouch, and inside a shipping box.The microcatheter used during the event was not returned for analysis.Additionally, the model and size were not reported.¿visual inspection/damaged location details: the concerto coin was found retracted out of the lumen stop, and the implant coil was already detached and was not returned.The pusher wire was kinked at ~53.0cm and at ~34.0cm to 34.8cm from the shield coil end.The pusher was found broken at the break indicator with the two segments retained by the release wire, indicative of a detachment attempt.No other anomalies were found.¿testing/analysis: the concerto coil could not be used for resistance testing as the implant was already detached.¿conclusion: based on the reported information and device analysis, the customer¿s ¿coil resistance/stuck in catheter¿ report could not be confirmed.Possible causes of resistance in a catheter include, but are not limited to, inadequate hydration before the procedure, failure to maintain a continuous flush, an incompatible/damaged microcatheter, or tortuous anatomy.The pusher was observed to be damaged (kinked).It is possible that damage occurred during the attempt to push the coil into the microcatheter against the reported resistance.However, the damage would have prevented the device from fully inserting into the microcatheter, thereby preventing it from reaching the aneurysm site to be detached.Therefore, the kinking possibly occurred after the device was manually detached.As the implant coil and unknown microcatheter used in the event were not returned for analysis, any contribution of the implant coil and microcatheter to the reported resistance could not be determined.As the model and size of the microcatheter were not reported, compatibility could not be assessed.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 a concerto coil could not be advanced.No patient symptoms or complications were associated with this event.It was unknown what condition was being treated or what the patient's blood flow and vessel tortuosity were.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Additional information was received stating that the procedure was completed by using a new product.The cause of the resistance was not determined.

• 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: 24877836
• Report Number: 2029214-2026-00674
• Device Sequence Number: 18651752
• Product Code: KRD
• UDI-Device Identifier: 00847536045316
• UDI-Public: (01)00847536045316(17)261003(10)B647241
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 04/14/2026

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 Expiration Date: 10/03/2026
• Device Model Number: PV-12-40-3D
• Device Catalogue Number: PV-12-40-3D
• Device Lot Number: B647241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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