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

Model Number	PV-3-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note that two devices were returned and only one was found to have a reportable malfunction.However it could not be determined which device was which so both are reported conservatively.Product analysis #(b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361), pin gauge sets (m-84081, m-84082) document used: n/a as found condition (condition of returned device): two concerto implant coils were returned for analysis within a shipping box; within a sealed biohazard pouch; within opened concerto implant coil outer cartons and within opened concerto implant coil inner pouches.The concerto implant coils were returned within introducer sheath.Visual inspection/damage location details: due to the condition in which the concerto implant coils were returned it was unable to be determined which coil belongs to which pli.(coil 1) the introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The concerto coil pushwire was found to be bent at ~7.6cm from proximal end.The implant coil was found to be stretched and damaged.No other anomalies were observed.(coil 2) the introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The concerto coil pushwire was found to be broken at break indicator.The implant coil was found to be stretched and damaged within introducer sheath.The implant coil was unable to be pushed out further from introducer sheath for additional analysis as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): (coil 1) the concerto coil tip od (outer diameter) was measured to be 0.0106¿.The id (inner diameter) of the introducer sheath was measured to be 0.0185¿.(coil 2) the concerto coil tip od (outer diameter) was measured to be 0.0117¿.The id (inner diameter) of the introducer sheath was measured to be 0.019¿.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issues pushing the concerto coils out from within their introducer sheaths during preparation.Therefore, it is possible that the implant coils became damaged during return of the implant coils back into the introducer sheath.It is possible insufficient preparation of the concerto coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.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.
Event or Problem Description
It was reported that two concerto coils resistance and were stuck in the sheath prior to use.It was attempted to push the coil out from the original protection transparent sheath, but it was impossible to move it forward from the sheath.There were no patient symptoms or complications associated with this event.Additional information was received that the coil was found to be stuck in the protective sheath upon the first attempt to advance the coil from the sheath.During preparation, the introducer sheath was held horizontally when the implant coil was pulled back inside during hydration.A continuous saline flush was not administered and maintained as indicated in the ifu.

• 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: 22591444
• Report Number: 2029214-2025-01689
• Device Sequence Number: 18439355
• Product Code: KRD
• UDI-Device Identifier: 00847536045125
• UDI-Public: (01)00847536045125(17)270807(10)B784313
• 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): 07/24/2025

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-3-8-3D
• Device Catalogue Number: PV-3-8-3D
• Device Lot Number: B784313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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 Age: 69 YR
• Patient Sex: Male