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

Model Number	APB-1-3-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83360), pin gauge sets (m-84083, m-84081), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.The device was returned without its protective introducer sheath.Visual inspection/damage location details: the axium prime pusher was found broken at the break indicator with the release wire also broken (figure c).The axium prime implant coil was found to be damaged and knotted outside its introducer sheath (figure d).Testing/analysis: the axium prime device could not be used for resistance testing as the introducer sheath was not returned for anal ysis.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0110¿, which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) could not be measured as it was not returned for anal ysis.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the introducer sheath was not returned; however, the failure could not be ruled out.The implant coil was found damaged and knotted.It is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant.The resulting damage would contribute towards the reported ¿coil resistance/stuck in catheter¿.As the introducer sheath was not returned for analysis, any contribution of the introducer sheath towards the resistance could not be assessed and the condition of the coil at time of use could not be confirmed as the introducer is designed to protect the implant when not in use.The break indicator and release wire were found broken.The cause of the break could not be determined.It is possible the breaks are related to the reported resistance.This event is reported at this time based on analysis findings which indicated a reportable event.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the package was opened, the spring coil was taken out, and inserted it into the microcatheter, but found that it was difficult to operate and it could not be pushed.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured left middle cerebral artery aneurysm with a max diameter of 3 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information received reported the resistance was in the proximal end of the catheter.The coil did not come out of the in troducer sheath smoothly.Continuous saline flush was administered and maintained as indicated in the instruction for use (ifu).There was no damage observed to the coil or catheter ater removal.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 21883708
• Report Number: 9617601-2025-00402
• Device Sequence Number: 18093636
• Product Code: KRD
• UDI-Device Identifier: 00847536020924
• UDI-Public: 00847536020924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 04/22/2025

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-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: 227569908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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 Age: 59 YR
• Patient Sex: Male