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

Model Number	APB-3-8-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for arteriovenous malformations or fistulae.Abnormality located in the eloquent region and grade type were unknown it was noted that the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that during the surgery, an axium coil embolization was attempted to occlude the blood vessel.The coil was advanced from the catheter hub, but excessive resistance prevented it from being pushed out of the protective sheath.It was then retracted and another attempt was made to push it out, but it was unsuccessful.A coil of the same model was then used, and the surgery continued.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received stating that the cause of the resistance was related to the spring coil protective sheath.A continuous saline flush was administered and maintained as indicated in the ifu.During preparation, it was noted that the introducer sheath could not be pushed out and no retraction was observed when the implant coil was pulled back inside during hydration.
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
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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
H3: product analysis equipment used: video inspection system (m-85519), ruler (m-83361), pin gauge sets (m-84083, m-84081) drawing(s) referenced: d00176811 rev.B; dwgs50796 rev.A as found condition: the axium prime device was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found correctly assembled on the pusher with the wavelock at the proximal end.No damage or irregularities were found with the introducer sheath.No damage or irregularities were found with the axium prime pusher.The axium prime implant coil was found still attached to the pusher and found damaged within the introducer sheath.Testing/analysis: the axium prime implant coil could not be advanced out of the introducer sheath due to the damage and could not be used for resistance testing.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0112¿ which is within specification (specification: 0.0108¿ +.0010¿/-.0020¿).The introducer sheath id (inner diameter) was measured and found to be 0.0175¿ (0.4445mm) which is within specification (specification: 0.46mm ±0.02mm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ and ¿resistance/failure to resheath¿ were confirmed.The implant coil was found damaged within the introducer sheath, potentially contributing towards the resistance.However, it is also possible the damage will occur due to advancing against the reported resistance.Customer reported finding the failure during preparation.Therefore, manufacturing could not be ruled out.The likely 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.
Event or Problem Description
Additional information was received reporting that it was clarified that, "after being taken out from the packaging and hydration, the device was delivered through the protective sheath, but could not be pushed out of the protective sheath.".

• 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: 24387922
• Report Number: 9617601-2026-01306
• Device Sequence Number: 16024589
• Product Code: KRD
• UDI-Device Identifier: 00763000313746
• UDI-Public: (01)00763000313746(17)270103(10)228011100
• 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): 03/24/2026

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-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: 228011100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 03/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/17/2026; 03/24/2026
• 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: 62 YR
• Patient Sex: Female