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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil (model: apb-1.5-2-hx-es lot: b034019) was returned for analysis.No damages or anomalies were found with the outer carton and inner pouch with all seals accounted for but broken.The axium prime pusher was found kinked at the positive load indicator.The pusher was found broken at the break indicator with the two segments retained by the release wire.The coin was retracted out of the lumen stop with the implant coil already detached and not returned for analysis.No other anomalies were observed.Based on the device analysis and reported information, the customer's report of "pusher kink/broke" was confirmed and the customer report of "prod damaged/deformed out of pkg" cannot be ruled out.The axium prime pusher was found kinked and broken.As the dispenser coil (with the pushwire clip), implant coil and introducer sheath were not returned for analysis, any contribution the dispenser coil, implant coil and introducer sheath towards the pusher kink/break and damage out of packaging could not be determined.The implant coil detached as expected per design of the pusher and release wire.A formal investigation has been conducted regarding this issue.Based on the formal investigation, it is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.The review of device history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that after opening the package, it was found the axium coil pushwire was broken and could not be used.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the anterior communicating (acom) artery with a max diameter of 3 mm and a 2.5 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.Additional information was received reporting that there was no damage or evidence of tampering to the device packaging.The the package was opened, the proximal end of the pushwire was not secure in the guidewire clip.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11023897
• Report Number: 2029214-2020-01324
• Device Sequence Number: 10950879
• Product Code: KRD
• UDI-Device Identifier: 00847536032125
• UDI-Public: 00847536032125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 06/02/2023
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: B034019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR