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

Model Number	APB-2-3-3D-ES
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil pusher wire was broken when the product was advanced inside the mc, early detachment occurred.Damage was in the pusher distal region.There was no resistance during preparation or use.The device was prepared as indicated in the package insert and the continuous flush was administered during the procedure.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83360) as found condition: the axium prime coil was returned for analysis within a shipping box, within a primary plastic resealable pouch, and within a secondary plastic resealable pouch.Visual inspection/damage location details: the axium prime coil was returned with the pusher wrapped and tied onto itself, creating multiple bends and kinks on the pusher.In addition, the axium prime pusher was found bent at ~33.2cm from the pusher distal end.The pusher actuator interface (ai) was found intact.The pusher was found broken at the hypotube break indicator (hbi) with the release wire pulled for ~0.5cm.The release wire coin was found pulled back from lumen stop, the shield coil was found stretched, and the implant coil was detached.Conclusion: based on the device analysis and reported information, the customer¿s ¿pusher kink/broke¿ and ¿premature detachment¿ reports were confirmed.It is likely the implant coil became detached after the pusher was broken and the release wire pulled.However, the cause for the pusher break could not be determined.Regarding the kink found at the distal end of the pusher damage can occur if the device is advanced against resistance.However, the cause for the pusher kink 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: 14153008
• Report Number: 9612164-2022-01510
• Device Sequence Number: 5932578
• Product Code: KRD
• UDI-Device Identifier: 00847536021181
• UDI-Public: 00847536021181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 02/11/2024
• Device Model Number: APB-2-3-3D-ES
• Device Catalogue Number: APB-2-3-3D-ES
• Device Lot Number: 221689767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 06/08/2022
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown