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

Model Number	APB-3-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
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
Medtronic received a report that the physician wanted to treat the aneurysm with axium coils.He inserted the first coil into the aneurysm without any friction or problems.He used the instant detacher to detach the coil as described in the ifu; however, the coil was not detached.He used another instant detacher, but the coil was not detached.He did the "plan b" and broke the pusher wire proximal to detach the coil, but the coil was not detached.Finally, he removed the whole coil out of the body without any problems.He finished the procedure with other axium coils.There was non-detachment.The physician attempted to detach the coil with the instant detacher one time.The physician attempted to detach with another instant detacher one time.There was a manual attempt at detachment via hypotube one time.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of an m3 aneurysm.Ancillary devices include a envoy 6f guide catheter, echelon 10 45grad microcatheter.
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 reporting prior to the coil non-detachment, there were no abnormalities.The doctor tried new detachers several times, which never worked.Finally, the coil could be detached with the help of plan b.The doctor broke the proximal wire and was able to pull back the inner wire.The coil detached directly.There was no visible damage to the pushwire after removal from the patient.This information was confirmed with the physician/account.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (b)(4).Ruler (b)(4).Camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within shipping box; within a sealed tyvek biohazard pouch; within a sealed plastic biohazard pouch and within an opened axium prime inner pouch.The two instant detachers used during the event were not returned.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found separated from the remaining pusher.The three tack welds were found present but broken.The coin was found retracted out of the lumen stop.The shield coil was found stretched.The implant coil was already detached from the pusher and found entangled with the stretched shield coil.The coin was found damaged near the distal end.The lumen stop was found damaged.Conclusion: based on the analysis performed, the customer report of ¿non-detachment" was confirmed.The cause of the non-detachment is likely due to the coin becoming jammed within the lumen stop.The damages found to the lumen stop and coin is consistent with the coin being stuck.The shield coil was found stretched and the implant was found entangled with the shield coil which could have contributed to the non-detachment.H6.Coding updated based on analysis findings.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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19129188
• Report Number: 9612164-2024-01855
• Device Sequence Number: 20004310
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203432
• 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): 06/18/2024

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: 07/27/2024
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 222662774
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 05/23/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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