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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when the axium coil reached the neck of the aneurysm, it was found that there was no coil body entering the tip end.After withdrawing the axium coil, it was found that it had automatically detached.Then the spring coil of the same model was replaced, and the operation was successfully completed.The axium coil and any accessories were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of a saccular, unruptured posterior communicating (pcom) artery aneurysm with a max diameter of 3.7mm and a 2.4mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.  ancillary devices include a e10 microcatheter and an avigo guidewire.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received that there were no detachment attempts (instant detacher or manual method) made.There was no kink/d amage observed on the pushwire.
Additional Manufacturer Narrative
Product analysis #705893542: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an introducer sheath.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found unbroken.No evidence of detachment attempts was found at these locations with an instant detacher or by manual method.The pusher was found kinked at the break indicator.The coin was found still against the lumen stop.The shield coil was found intact.The implant coil was found broken at the coil shell weld.The detached portion of the implant coil was found stretched and damaged with the polypropylene filament broken.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿premature detachment¿ was confirmed.The cause of the detachment was found to be the break found with the implant coil, separating the implant coil from the remaining device.Possible causes for coil break are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant during repositioning, pushwire rotation, or user advances/retracts the coil against resistance.Customer only reported that the devices were prepared per ifu, and vessel tortuosity as normal.Therefore, the likely cause cannot be determined.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 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17957433
• Report Number: 9612164-2023-04731
• Device Sequence Number: 5119057
• Product Code: KRD
• UDI-Device Identifier: 00763000313647
• UDI-Public: 00763000313647
• 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
• Report Date (Section B): 01/05/2024

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: 11/30/2025
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: 225549342
• 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: 10/16/2023
• Supplement Date Received by Manufacturer: 12/16/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 67 KG