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 Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received that there was no damage to packaging and the package was intact.The proximal end of the pushwire was secured in the guidewire clip when the package was opened.
Additional Manufacturer Narrative
H3: product analysis of apb-3-6-3d-es, lot#226508422 as found condition: the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the axium prime pusher was found broken at the break indicator with the release wire fully retracted out of the pusher.The proximal pusher segment and release wire were not returned for analysis.The pusher was found kinked at ~151.5cm from the proximal end.The coin was found fully retracted out of the lumen stop.The shield coil was found damaged, and the implant coil was already detached and not returned for analysis.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil kink/damaged¿ could not be confirmed as the implant coil was already detached and not returned.The shield coil was found damaged.Possible causes for coil damage are patient vessel tortuosity or advancing against resistance.Customer reported no friction or difficulty during testing/delivery, continuous flush was not administered, no repositioning was performed, devices were prepared per ifu, and patient vessel tortuosity as normal.The implant was found already detached.The pusher was found broken at the break indicator and the release wire was fully retracted, detaching the implant coil as expected by the detachment subassemblies.However, the customer did not report any detachment attempts.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil kink/damage could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18094136
• Report Number: 9612164-2023-05118
• Device Sequence Number: 5823500
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/08/2023

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: 05/12/2026
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 226508422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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