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

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis of apb-4-12-3d-ss, lot# 224797389 as found condition: the axium prime coil was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch and within a dispenser coil.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the axium prime pusher was found bent at 113.4cm and found kinked at 166.6cm from the proximal end.The shield coil was found intact.The axium prime implant coil was found broken from the detach element and not returned for analysis.No damages or irregularities were found with the detach element.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ could not be confirmed; however, the customer report of ¿coil separation/break¿ was confirmed.Therefore, coil stretch is likely to have occurred as implant coils usually stretch before breaking.It is likely the implant coil stretched/broke, and the pusher became bent/kinked due to advancing/retracting the device against the reported ¿coil resistance/stuck in catheter¿.The cause of the resistance cannot be confirmed.Customer reported devices were prepared per ifu, no repositioning of the coil, no rotation of the pusher during procedure, continuous flush was administered, and vessel tortuosity was minimal.As the implant coil and echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the implant coil and echelon-10 micro catheter towards the resistance, coil stretch, and coil break could not be determined.The axium prime coil is compatible for use with the echelon-10 micro catheter.There is no indication that the event is related to a potential manufacturing issue.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 was received that clarified that the report of the coil separation/break/ premature detachment was only referring to the coil stretch.It was noted that part of the coil did not fracture and separate from the rest and the coil did not prematurely separate from the delivery wire.

• 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: 16953640
• Report Number: 9612164-2023-02105
• Device Sequence Number: 15214128
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• 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): 05/18/2023

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: 07/30/2025
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: 224797389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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 Sex: Unknown