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

Model Number	APB-4-8-3D-SS
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received report that after the first coil had been delivered and deployed successfully to form the hoop, the axium coil (model: apb-4-8-ss, lot: 228091510) was delivered for filling.However, it was reported that the coil development was abnormal despite there being no feeling of abnormality during delivery.The coil was withdrawn and redelivered but still was not shaped normally so it was withdrawn from the patient's body and found to be stretched in the "pushwire middle segment." it was noted that the axium coil and all accessory devices were prepared per the instructions for use.There was no observed friction or other difficult during testing or delivery of the coil.Continuous catheter flush was administered during the procedure.The physician did not reposition the coil.The coil was replaced to continue the procedure.Ancillary devices: cook sheath, echelon microcatheter, avigo guidewire there was no harm or injury to the patient who was undergoing a coil embolization procedure to treat an left internal carotid artery (l-ica) ophthalmic segment unruptured saccular aneurysm.The aneurysm max diameter was 5mm and the neck diameter was 2.6mm.Blood flow and vessel tortuosity were normal.Additional information received reported that there were no known issues that resulted in the damage that was found.
Additional Manufacturer Narrative
The event is reported at this time based on analysis findings with indicated a reportable event.H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): the axium prime coil and was returned for analysis within a shipping box; within a sealed biohazard plastic pouch and within its opened axium prime inner pouch.The axium prime coil was returned without introducer sheath.Visual inspection/damage location details: the axium prime coil pushwire was found to be bent at ~4.4cm from proximal end.The axium implant coil was found to be broken and returned.The axium prime coil was found to be stretched and damaged.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed.There was no reported issue pushing the axium prime coil out from within the introducer sheath.Therefore, it is possible the axium coil became damaged upon removal from within the introducer sheath; however, the root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil shape-poor shape outside sheath¿ was unable to be confirmed.A possible cause for ¿coil shape-poor shape outside sheath¿ is damaged coil.It is possible the damage to the implant coil contributed to the reported failure.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; 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: 20052127
• Report Number: 9612164-2024-03836
• Device Sequence Number: 7998626
• Product Code: KRD
• UDI-Device Identifier: 00847536008168
• UDI-Public: 00847536008168
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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-4-8-3D-SS
• Device Catalogue Number: APB-4-8-3D-SS
• Device Lot Number: 228091510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: 13 YR
• Patient Sex: Male