MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, within a biohazard paper pouch, within a biohazard plastic pouch, within an opened axium prime inner pouch, and within an introducer sheath coil.Damage location details: the introducer sheath was found to be applied correctly, with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was found to be broken at ~4.2cm, with the hypotube detached from the pushwire.In addition, the pushwire was found to be bent within the introducer sheath at ~46.6cm, bent at ~14.8cm and kinked at ~7.7cm from the distal end.The axium prime implant coil was found to be stretched and damaged within the introducer sheath.In addition, the polypropylene filament was intact with the detachable element.The axium prime implant coil was unable to advance out of the introducer sheath.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime implant coil tip od (outer diameter) was measured to be 0.0109¿, which was found to be within specification (specification 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured to be.018¿ (0.46mm), which was found to be within specification (specification 0.46mm +0.02m/-0.02mm).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 an axium coil encountered resistance and was stuck in the sheath.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).  there was no patient involvement.Ancillary devices include an echelon microcatheter.Additional information received reported that the cause of the resistance was not determined.A continuous saline flush had been administered and maintained as indicated in the ifu.The introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• Brand Name: AXIUM PRIME BRPL 3D
• 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: 22512091
• Report Number: 2029214-2025-01595
• Device Sequence Number: 15639901
• Product Code: KRD
• UDI-Device Identifier: 00763000313753
• UDI-Public: (01)00763000313753(17)280106(10)230393702
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203432
• 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): 07/15/2025

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: APB-3.5-6-3D-ES
• Device Catalogue Number: APB-3.5-6-3D-ES
• Device Lot Number: 230393702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 01/06/2025
• 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 Sex: Unknown