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

Model Number	APB-4-8-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil was stuck in sheath.The devices were prepared as indicated in the ifu.
Additional Manufacturer Narrative
The pushwire was returned for evaluation inside of a biohazard bag and a shipping box.There was no implant coil and introducer sheath returned with the pushwire.Visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil was present with no damage.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the break indicator (manual detachment location); retained by the release wire.The ai and coupler tubing were found present and intact.The pushwire was found to be bent at 33.0cm to 61.0cm from the proximal end.Testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.073mm @ 0.063mm; measured 0.080mm @ 0.127mm; measured 0.092mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00270" and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00459¿ and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.Conclusion: based on the analysis performed, the axium prime coil was not confirmed to have "coil resistance/stuck in sheath" as the pushwire was returned with the implant coil already detached and without the introducer sheath.However, the root cause could not be determined.The pushwire was found broken at manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the implant coil and introducer sheath were not returned; any contribution of the implant coil and introducer sheath to the reported issue could not be determined.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: 13906272
• Report Number: 2029214-2022-00481
• Device Sequence Number: 4596399
• Product Code: KRD
• UDI-Device Identifier: 00847536031999
• UDI-Public: 00847536031999
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: 03/24/2024
• Device Model Number: APB-4-8-3D-SS
• Device Catalogue Number: APB-4-8-3D-SS
• Device Lot Number: B181333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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