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

Model Number	APB-1-2-HX-ES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that was broken at the detachment point.The patient was undergoing a coil embolization procedure to treat an unruptured saccular aneurysm located at the c7 posterior communicating artery (pcom) segment.The aneurysm had a max diameter of 2.5mm and a neck diameter of 2mm.Patient's blood flow was normal.Patient's vessel tortuosity was minimal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instruction for use (ifu).A 1.5-3 coil was delivered and deployed successfully as the first coil in the procedure.An axium coil (apb-1-2-hx-es) was then selected.However, when the protective sheath was removed, it was observed that the detachment point of coil was broken so the coil was not used.It was replaced with another coil of the same model which was successfully placed.No significant contrast agent retention observed in the aneurysm.The procedure was completed without any patient symptoms or complications.
Additional Manufacturer Narrative
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
Additional information was received that there were no detachment attempts.There was no kink/damage observed on the pushwire.It was reported that after the coil was removed and standard hydration was performed, the coil was found to be abnormal in shape under the dsa machine when preparing for embolization.The coil was then pushed out for observation and the detachment point was found to be broken.Considering the surgical risk, the coil was replaced.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product analysis # (b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within sealed biohazard pouch and within a dispenser track.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The pushwire was found to be broken but retained by release wire at break indicator.The coin was found still against the lumen stop.The shield coil was found intact.The implant coil appeared to be still attached, stretched and damaged within introducer sheath.The implant coil was pushed out of introducer sheath for additional analysis.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwire was returned with the implant coil still attached.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: 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: 21072967
• Report Number: 9617601-2025-00025
• Device Sequence Number: 8386442
• Product Code: KRD
• UDI-Device Identifier: 00763000313791
• UDI-Public: 00763000313791
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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,Followup,Followup
• Report Date (Section B): 03/13/2025

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-1-2-HX-ES
• Device Catalogue Number: APB-1-2-HX-ES
• Device Lot Number: 228012937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: 67 YR
• Patient Sex: Female