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

Model Number	APB-1.5-2-3D-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	05/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when treating a right posterior communicating segment aneurysm, when opened the package of a 1.5x2 spring coil, found that the detachment point was kinked.After replacing it with a new spring coil of the same model, the implantation was successful.No patient symptoms or further complications were reported as a result of this event.The reported device and any accessory devices prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the posterior communicating artery segment with a max diameter of 4.2mm and a 2.3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information was received that there was no damage or evidence of tampering to device packaging.The proximal end of the pushwire was sealed in the guidewire clip when the package was opened.
Additional Manufacturer Narrative
H3: product analysis of apb-1.5-2-3d-es, lotno:227006318 as found condition: the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and outside its returned dispenser coil.The original packaging and introducer sheath were not returned for analysis.Visual inspection/damage location details: the returned dispenser coil was not the original dispenser coil packaged with the axium prime.The black guidewire clip was not attached to the returned dispenser coil.The axium prime pusher was found broken at the break indicator with the release wire and coin fully retracted out of the pusher.The shield coil was found broken.The implant coil was found already detached from the implant coil and not returned for analysis.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿pusher kink/damage¿ was confirmed.The pusher was found broken, with the release wire/coin retracted out of the lumen stop, detaching the implant coil as designed by the detachment elements.As the black guidewire clip, introducer sheath, implant coil and original packaging were not returned, any contribution of the black guidewire clip, introducer sheath, implant and packaging to the failure could not be determined.It is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.The likely cause could not be determined.There is an indication that this could potentially be caused by a potential manufacturing issue and a dhr review is required.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 BARE PL 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19763852
• Report Number: 9612164-2024-03289
• Device Sequence Number: 8604903
• Product Code: KRD
• UDI-Device Identifier: 00847536021143
• UDI-Public: 00847536021143
• 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): 07/17/2024

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: 07/20/2026
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: 227006318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: 66 YR
• Patient Sex: Female