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

Model Number	APB-2-6-HX-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received report that once the package was opened, the axium coil pushwire was observed to be kinked.The coil was pushed out and found to be already detached.It was noted the device was prepared per ifu but was not used in the procedure.No patient was involved.
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
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 reported that there was no damage or evidence of tampering to device packaging.No prep performed prior to the damage being seen.The proximal end of the pushwire secured in the guidewire clip (black rubber stopper) when the package was opened.The pusher wire kinked.
Additional Manufacturer Narrative
H3.Product analysis:equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within an opened axium prime coil outer carton; within an opened axium prime coil inner pouch and within a dispenser track.Visual inspection/damage location details: the axium prime coil was returned within introducer sheath.The pushwire was found to be kinked at ~1.1cm from proximal end.The actuator interface, positive load indicator, and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be broken but retained by release wire at load indicator.The coin was found to be still against the lumen stop.The implant coil was already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): under the microscope, the outer jacket was then removed to gain access to the coin.The coin appeared to be damaged and lost teardrop shape.The coin was unable to be measured accurately.The lumen stop appeared to be visually acceptable.The retainer ring was found to be visually acceptable and measured to be 0.0052¿ which is within specification.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 cause could not be determined.Since the implant coil and included detach, element were not returned for analysis, any contributing factors could not be determined.Based on the analysis performed, the customers report of ¿product deformed/damaged out of pkg¿ was confirmed as the pushwire was found to be returned damaged (kinked/broken), and not secured within the rubber stopper; however, the cause could not be determined.Since the implant coil and included detach element were not returned for analysis, any contributing factors could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was confirmed.Pushwire damage can occur if the user advances the device against resistance.However, there was not any friction or difficulty during testing or delivery.Therefore, the cause for the pushwire kink could not be confirmed.H6.Coding updated based on analysis results.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 HLX
• 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: 15234503
• Report Number: 2029214-2022-01382
• Device Sequence Number: 17339713
• Product Code: KRD
• UDI-Device Identifier: 00847536021013
• UDI-Public: 00847536021013
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 02/10/2023

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: 09/15/2024
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 222935132
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 01/11/2023
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/07/2022; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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