MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coil encountered resistance in the sheath.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left posterior communicating artery with a max diameter of 3.4mm and a 1.8mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that for left posterior communicating artery aneurysm, during the operation, the stent was first placed and then filled the coil.When filling the coil, apb-3-6-3d-es was selected as the first coil.There was no abnormal hydration and the pushing resistance was extremely high.Then, they withdrew the microcatheter and coil, pulled out the abnormal coil, and operated again outside the body.The push resistance remained the same.The mesh was re-pierced for filling, and apb-2.5-4-3d-es was re-selected for embolization.The operation went smoothly.The reported device and any accessory devices prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information received reported during preparation, the introducer sheath held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis (m-85519) 203cm ruler (m-83361) pin gauges (m-84081) (m-84083) as found condition (condition of returned device): the axium prime implant coil was returned for analysis within a shipping box; returned within a sealed plastic biohazard pouch and returned within a dispenser coil.Damage location details: the axium prime implant coil was returned within an introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The introducer sheath was returned in good condition.The pushwire was found to be bent within the introducer sheath at ~16.8cm and bent at ~6.1cm from the distal end.The axium prime implant coil returned without the coil (detached).The axium prime implant coil was able to advance out of the introducer sheath without any issues.No other anomalies were observed.Testing/analysis (including sem reports): the axium prime implant coil tip od (outer diameter) could not be measured.The introducer sheath id (inner diameter) was measured to be.0175¿ (0.44mm) which was found to be within specification (specification 0.46mm +0.02mm/-0.02mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed, and the root cause for resistance was unable to be determined.The axium prime pushwire was returned damaged (bends) and the implant coil was found to be missing, therefore any contribution to resistance caused by the implant coil was unable to be assessed.Advancing the axium prime coil against resistance could lead to possible damage which may lead to possible resistance within the introducer sheath.The customer reported that the devices and any accessory devices were prepared as indicated in the instructions for use (ifu).The customer reported that during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.Possible causes for resistance are, but not limited to damage during preparation, overtightening of rhv, improper hubbing technique, and blood in sheath (lack of continuous flush).This event is reported at this time based on conservative review of analysis results which indicate the possibility of a reportable device malfunction.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.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19607721
• Report Number: 9612164-2024-02987
• Device Sequence Number: 12883261
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: 00763000313739
• 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
• Report Date (Section B): 06/25/2024

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-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 227626106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2023
• 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: 54 YR
• Patient Sex: Female