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

Model Number	APB-2.5-6-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil was found to be detached during the flushing process.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in the right middle cerebral artery with a max diameter of 3.5 mm and a 3.3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that after the axium coil package was opened, the tip was found to be detached during the water washing process and could not be implanted normally.It was reported there was coil separation/break/premature detachment.The implant coil was removed from the patient by removing with the microcatheter.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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
Additional information was received.The cause of the premature detachment determined was not determined.The patient did not experience any adverse events or injury.The aneurysm was right middle cerebral artery aneurysm, 3.5*2.8.Vessel tortuosity was normal.The procedure was completed, stent-assisted coil to fill.One was filled before and two were filled after this malfunctioned coil.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis biohazard pouch; within an opened axium prime inner pouch; within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.A small amount of dried blood was found within the introducer sheath and on the distal implant (figure f).The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The shield coil was found undamaged.The implant coil still attached to the pusher.The implant coil was found slightly damaged within the introducer sheath (figure g).No breaks were found with the implant coil.Testing/analysis: the axium prime implant coil was found stuck within introducer sheath and became stretched during extraction (figures h and i).The implant coil was confirmed still attached to the pusher.No other anomalies could be observed.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was not confirmed.The implant coil was returned still attached to the pusher.Customer reported the premature detachment occurred during the flushing process; however, blood was found within the introducer sheath and on the implant, indicative of use.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: 19447164
• Report Number: 9612164-2024-02643
• Device Sequence Number: 8747158
• Product Code: KRD
• UDI-Device Identifier: 00763000313715
• UDI-Public: 00763000313715
• 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,Followup,Followup
• Report Date (Section B): 08/19/2024

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: 08/19/2026
• Device Model Number: APB-2.5-6-3D-ES
• Device Catalogue Number: APB-2.5-6-3D-ES
• Device Lot Number: 227179020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 07/23/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/01/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2023
• 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: 57 YR
• Patient Sex: Male