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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5 as found condition: the axium prime coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and partially within an introducer sheath.A second axium priem coil was also returned and will be addressed in pli-10.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium prime pusher was found kinked at ~108.4cm from the proximal end.The axium prime implant coil was found severely stretched and broken with the polypropylene filament broken.The distal portion of the implant coil was found already deployed out of the distal end of the sheath.The distal tip was separated from the implant coil and not returned for analysis.Testing/analysis: the axium prime coil could not be advanced out of the introducer sheath as it was found to be stuck.The implant coil tip outer diameter (od) could not be measured as it was not returned for analysis.The introducer sheath inner diameter (id) was measured to be 0.0175¿ (0.4445mm), which is within specification (specification: 0.046¿ ± 0.002¿).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.The implant coil was found stretched/broken and the pusher was found kinked.There were no reported issues pushing the axium prime implant coil from within the introducer sheath during hydration per ifu.Therefore, it is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing/retracting the coil against resistance would result in damages to the implant/pusher.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
Medtronic received a report that after the axium coil hydration, the axium coils could not be pushed out of the protective sheath.After another coil was replaced, it was pushed out of the protective sheath smoothly, and the operation was completed smoothly.The axium coils 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 left posterior communicating (pcom) artery  aneurysm with a max diameter of 4.3mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Additional information received reported that during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• 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: 18059038
• Report Number: 9612164-2023-04996
• Device Sequence Number: 7729793
• Product Code: KRD
• UDI-Device Identifier: 00763000313722
• UDI-Public: 00763000313722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/02/2023

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: 08/14/2024
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 222760620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2021
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG