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

Model Number	APB-4-8-HX-SS
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: video inspection system (m-85519), ruler (m-83361), 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; within a dispenser coil and within an introducer sheath.The unknown micro catheter used in the event was not returned for analysis.Two other axium prime devices were also returned and will be addressed in pli-10 and pli-20.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found stretched and damaged within the introducer sheath with the polypropylene filament broken.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed.Possible causes of failure are lack of hydration, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant during repositioning, damaged micro catheter, incompatible micro catheter, pushwire rotation or user advances the coil against resistance.Customer reported devices were prepared per ifu and vessel tortuosity was normal.As no other information was provided, likely cause could not be determined.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil stretch could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.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 report regarding three different axium coils that were stretched during the procedure.Each time the stretched coil was replaced and the replacement coil was implanted successfully.It was noted that all involved devices were prepared as indicated in the instructions for use (ifu).Patient vessel tortuosity was reported to be normal.There was no harm or injury to the patient.Additional information received that there were no issues that resulted in the damage that was found.There was no friction or other difficulty during delivery or positioning.The continuous catheter flush was administered during the procedure.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 19617736
• Report Number: 9612164-2024-03013
• Device Sequence Number: 6974622
• Product Code: KRD
• UDI-Device Identifier: 00847536008175
• UDI-Public: 00847536008175
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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 Expiration Date: 02/25/2026
• Device Model Number: APB-4-8-HX-SS
• Device Catalogue Number: APB-4-8-HX-SS
• Device Lot Number: 226052108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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 Sex: Prefer Not To Disclose