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

Model Number	APB-2-4-3D-ES
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The axium prime coil (model: apb-2-4-3d-es lot: a771108) was returned for analysis.The dispenser coil and black rubber guidewire clip were not returned for analysis.No irregularities were found with the returned packaging material.The opened outer carton and inner pouch has all seals accounted for.No damages or irregularities were found with the introducer sheath.The axium prime pusher was found broken at the break indicator.The release wire was fully retracted out of the distal pusher segment.The release wire was still attached to the proximal segment.The pusher was found kinked at 119.6cm from the proximal end of the distal segment.What appears to be dried blood was found coagulated on the shield coil.The implant coil was already detached.The implant coil was found stretched with the polypropylene filament broken.No other damages or anomalies were observed.Based on the device analysis, reported information, and customer device image, the customer¿s report of ¿pusher bent¿ and ¿prod damaged/deformed out of pkg¿ were confirmed as the pusher was found to kinked; however, the cause could not be determined.Additional damages to the device were found beyond those the customer reported.The pusher was found kinked/broken, the release wire was fully retracted out of the pusher and the implant coil was found stretched with the polypropylene filament broken.In addition, what appears to be coagulated blood was found on shield coil, indicative that the device was potentially used.As the dispenser coil and guidewire clip was not returned for analysis, any contribution of the dispenser coil and guidewire clip to the ¿pusher kink/broke¿ and ¿prod damaged/deformed out of pkg¿ could not be assessed.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.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 lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Therefore, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when the axium coil was taken out of the packaging, it was bent on the proximal segment of the delivery wire.The physician decided to use another coil of the same size from another manufacturer to complete the procedure.There was no patient involvement indicated with this event.The physician noted that there no damage or evidence of tampering to device packaging, the proximal end of the pushwire was secured in the guidewire clip when the package was opened.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10788377
• Report Number: 2029214-2020-01099
• Device Sequence Number: 19766341
• Product Code: KRD
• UDI-Device Identifier: 00847536021198
• UDI-Public: 00847536021198
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 01/22/2022
• Device Model Number: APB-2-4-3D-ES
• Device Catalogue Number: APB-2-4-3D-ES
• Device Lot Number: A771108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1