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

Model Number	APB-5-15-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when the axium coil was inserted and the sheath was removed, it got caught on the wire, the sheath could not be removed from the wire, so it was collected.Initially, 5 mm×10 mm was used but the sheath could not be removed; the size was changed to 5 mm×15 mm, but again, the sheath could not be removed, so it was collected in the same manner.When trying to remove the sheath, pulled hard enough that it stretched, but it would not come out.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There is no patient involved in this event.
Additional Manufacturer Narrative
H3: product analysis as found condition: two axium prime devices were returned for analysis within a shipping box and within individual resealable plastic biohazard pouches.One axium prime device was returned outside its returned introducer sheath.The second axium prime device was returned with the proximal pusher within the introducer sheath.It is not possible to determine which device belongs to which pli, therefore the two devices will be analyzed together.Visual inspection/damage location details: (first axium prime device) 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 to be damaged and stretched with the polypropylene filament broken.(second axium prime device) the introducer sheath was found stretched and kinked between ~82.0cm and ~72.5cm from the proximal end.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found to be damaged and stretched with the polypropylene filament broken.Testing/analysis: (first axium prime device) the axium prime device could not be used for resistance testing due to the damaged condition.The axium prime implant coil tip od could not be measured as it was damaged.The introducer sheath id (inner diameter) was measured and found to be 0.0185¿ (0.4699mm) which is within specification (specification: 0.47mm +0.03mm/-0.0mm).The coupler tube (thickest part of the pusher) outer diameter was measured to be 0.0170¿, which is within specification (= 0.0175¿).(second axium prime device) the axium prime device could not be used for resistance testing due to the damaged condition.The proximal pusher was removed from the introducer sheath with a very slight resistance encountered.The axium prime implant coil tip od could not be measured as it was damaged.The introducer sheath id (inner diameter) was measured and found to be 0.0190¿ (0.4826mm) which is within specification (specification: 0.47mm +0.03mm/-0.0mm).The coupler tube (thickest part of the pusher) outer diameter was measured to be 0.0175¿, which is within specification (= 0.0175¿).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ (sheath unable to be removed proximally) was not confirmed for the first axium prime device.The reported introducer sheath stretching was also not confirmed.There were no non-conformances to specifications found with the coupler tube or introducer sheath that would cause the reported resistance.The pusher should be able to pass freely through the introducer sheath.The customer report of ¿coil resistance/stuck in sheath¿ and ¿damaged introducer sheath¿ were confirmed for the second axium prime device.A slight resistance was found with the proximal pusher and introducer sheath when removing.The cause of the resistance could not be determined.In addition, the inner diameter of the sheath and outer diameter of the pusher were found within specification, which indicates that there should be no resistance.Both device implant coils were found stretched/damaged.Possible causes for implant damage are advancing/retracting against resistance or damaged during handling/return shipping as the implants were returned outside their protective dispenser coils and introducer sheaths.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 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: 20669495
• Report Number: 9617601-2024-00302
• Device Sequence Number: 18200717
• Product Code: KRD
• UDI-Device Identifier: 00847536008212
• UDI-Public: 00847536008212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/12/2024

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-5-15-3D-SS
• Device Catalogue Number: APB-5-15-3D-SS
• Device Lot Number: 227852235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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: Unknown