MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1-4-3D-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the axium prime spring coil was found to be stretched in the introducer sheath during product flushing.The product was replaced, and the patient did not experience any injury or complications.Additional information was received that the coil was inspected prior to flushing and did not become stretched during the flushing process.There were no issues that resulted in the damage that was found.There was no damage or evidence of tampering to the device packaging.The proximal end of the pushwire was secured in the guidewire clip when the package was opened.The devices were prepared according to the instructions for use (ifu).
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, an opened axium prime inner pouch, a dispenser coil, and within an introducer sheath.Damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The pushwire was found to be bent at ~7.0cm from the proximal end; in addition, the pushwire was found to be bent within the introducer sheath at ~13.1cm from the distal end.The axium prime implant coil was returned stretched within the introducer sheath.The polypropylene filament was found to be broken off the detachable element.No other anomalies were observed.Testing/analysis (including sem reports): during testing, the axium prime device failed to advance out of the introducer sheath.Due to the damaged condition no further testing was performed.*conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil stretch¿ was confirmed.The axium prime device was returned damaged with the implant coil stretched within the introducer sheath.The report states ¿the axium prime spring coil was found to be stretched in the introducer sheath during product flushing.¿; therefore, a possible cause of the ¿coil stretch¿ may have been caused during preparation.The report mentioned that the implant coil was inspected prior to being flushed and was found to be undamaged; therefore, the damage (stretching) may have been caused during the resheathing of the implant coil; however, the likely cause of the ¿coil stretch¿ was unable to be determined.A few other possible causes of ¿coil stretch¿ are, but not limited to, damage during preparation, pushwire rotation, and the user advances the coil against resistance.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: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22810255
• Report Number: 9617601-2025-00988
• Device Sequence Number: 7836722
• Product Code: KRD
• UDI-Device Identifier: 00763000313630
• UDI-Public: (01)00763000313630(17)270226(10)228342419
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/14/2025

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-1-4-3D-ES
• Device Catalogue Number: APB-1-4-3D-ES
• Device Lot Number: 228342419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: Female