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

Model Number	APB-2-4-3D-ES
Medical Device Problem Codes	Break (1069); Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
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
Medtronic received information regarding an axium coil that stretched during delivery and separated/broke.The patient was undergoing a coil embolization procedure to treat a right middle cerebral artery (mca) unruptured saccular aneurysm.The aneurysm max diameter was 7mm and the neck diameter was 4mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil and all accessory devices were prepared and continuous catheter flush was administered according to the instructions for use (ifu).There was some friction/difficulty during delivery.During the filling process, when only about 1cm of the coil remained to be delivered, there was a sudden stretching of the coil; the coil broke though it was noted the coil was not detached.It was noted that the coil was repositioned twice but the physician did not rotate the delivery pusher or try to detach the coil during the procedure.The coil was removed from the patient's body using solitaire ab (sab); no other surgical or medicinal intervention was required.The pushwire was not bent or broken.The coil was replaced to complete the procedure successfully.There were no patient symptoms or other complications associated with this event.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within sealed biohazard pouch; within an opened axium prime coil inner pouch and within a dispenser track.The axium prime coil returned within introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium coil pushwire was found to be broken at break indicator.The shield coil was found stretched with the implant coil found to be already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime coil could not be used for resistance testing due to its damaged condition.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 detached and not separated/broken.Possible causes for ¿coil separation/break¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.There is no indication that the event is related to a potential manufacturing issue.Based on the analysis performed, the customers report of ¿coil stretch¿ was unable to be confirmed as the implant coil was detached and not returned.Possible causes for ¿coil stretch¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.Based on the analysis performed, the customers report of ¿coil resistance stuck in catheter¿ was unable to be confirmed.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.
Additional Manufacturer Narrative
B5 updated with additional information received.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 received reported the coil came out of the introducer sheath smoothly.The resistance was in the distal end of the catheter.The catheter was not a medtronic device.

• 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: 21138652
• Report Number: 9617601-2025-00058
• Device Sequence Number: 20572326
• Product Code: KRD
• UDI-Device Identifier: 00763000313692
• UDI-Public: 00763000313692
• 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): 03/28/2025

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-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: 228767284
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 01/15/2025; 03/03/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/05/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: 50 YR
• Patient Sex: Female