MAUDE Adverse Event Report: Micro Therapeutics, Inc. dba ev3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	PV-14-30-HELIX
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the product was damaged upon opening the package.The assumption was that it was damaged during man ufacturing.It was noted that the patients' blood flow was normal and vessel tortuosity was moderate.All devices were prepared as indicated in the ifu and no patient complications were associated with this event.Additional information received reported the pusher wire was not secured in the black rubber stopper when the package was opened.There was no damage to the box or internal packaging.There was identified cause or contributing factor for the out-of-package damage to the concerto coil device.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): a concerto device was returned for analysis within a shipping box; within a sealed tyvek biohazard pouch; within its opened concerto implant coil outer carton; within an opened concerto implant coil inner pouch and within a dispenser track.Visual inspection/damage location details: the concerto device was returned with its introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The concerto pushwire was found to be kinked at ~7.0cm from proximal end and broken but retained by release wire at break indicator.The implant coil was found to be already detached and not returned.No other anomalies were observed.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil kink/damage¿ was unable to be confirmed as the concerto implant coil was detached and not returned.There were no reported issues pushing the concerto implant coil from within the introducer sheath during preparation per ifu.It is likely the detachment was due to the pushwire break at break indicator causing the release wire to be pulled back and releasing the implant coil.It is possible the damage (break/bent) to the pushwire occurred upon opening the package and attempting to remove the product or after removing it from the package and preparing it per ifu.The customer reported preparation was completed to the coil.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was unable to be confirmed as the damages found do not appear to be consistent with damage out of package.It is possible the damage (kink) occurred during production or upon opening the package and attempting to remove the product from the package.The customer reported preparing the concerto coil per ifu.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿part missing/incomplete/loose¿ was confirmed as the concerto was returned with pushwire not secured within black rubber stopper.However, the unsecured condition was likely attributable to the observed pushwire break, which may have prevented the pushwire from remaining properly secured within the rubber stopper upon return.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 ; +1(763)526-5677
• MDR Report Key: 50898568
• Report Number: 2029214-2026-01919
• Device Sequence Number: 6026568
• Product Code: KRD
• UDI-Device Identifier: 00847536045026
• UDI-Public: (01)00847536045026(17)280213(10)D025069
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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-14-30-HELIX
• Device Catalogue Number: PV-14-30-HELIX
• Device Lot Number: D025069
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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 Age: 75 YR
• Patient Sex: Male