MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil was used as the initial coil for aneurysm embolization.The surgeon found that the formed hoop was not ideal.When the surgeon wanted to retract and adjust it, the surgeon found that the axium coil had detached itself and stretched.Used the solitaire ab stent to pull out the axium coil, replaced it with another axium coil of the same model, and successfully completed the operation.After the operation, the product in question was collected and found that there was indeed no trace of detachment at the end of the axium coil push rod.There was no additional medical intervention needed.The pushwire was not bent or broken.There was no friction or difficulty during delivery and the physician did not reposition the axium coil.The physician did not rotate the delivery pusher during the procedure and continuous flush was administered during the procedure.The axium coil and any accessories were prepared as indicated in the instructions for use (ifu).  the patient was undergoing surgery for treatment of a saccular, unruptured anterior communicating (acom) artery aneurysm with a max diameter of 6mm and a 4mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
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.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a sealed biohazard pouch and within a dispenser track.The axium prime coil was returned without introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be intact but retained by inner liner at ~142.4cm from proximal end.The coin was found to be not against the lumen stop.The implant coil was already detached and returned.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium prime was returned with the implant already detached; however, the pushwire was broken with release wire pulled back, releasing the implant coil.Since the included detach element was not returned for analysis; therefore, any contributing factors could not be determined.A possible cause for premature detachment is the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.It is likely the detachment was user error as the pushwire was found to be broken with release wire pulled back, in turn releasing the implant coil.However, the root cause could not 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 BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17964551
• Report Number: 9612164-2023-04748
• Device Sequence Number: 6565305
• Product Code: KRD
• UDI-Device Identifier: 00847536038240
• UDI-Public: 00847536038240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2025
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: 224889255
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: 67 YR
• Patient Sex: Male