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

Model Number	APB-6-15-3D-SS
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil was returned without a dispenser coil and outside its returned introducer sheath.The axium prime coil was decontaminated.No damages or irregularities were found with the introducer sheath.The axium prime positive load indicator marker was found pealing.The pusher was found kinked and broken at the distal end.The coin was found still against the lumen stop.The shield coil was found still intact.The detach element was still attached to the pushwire with the implant coil broken from the detach element, with the implant coil broken and not returned.All other subassemblies appeared to be normal and no other anomalies were observed.The axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.The vessel tortuosity as normal.The report of ¿pusher kink/broke¿ was confirmed.The positive load indicator marker was found pealing, the pusher was found kinked, broken and the implant coil was found broken.It is likely that the damage to the axium prime pushwire and implant coil occurred during the attempt to advance/retract the coil through the micro catheter against the reported resistance.Other possible causes for pushwire/implant damage are: lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the imp lant pusher during repositioning, pushwire rotation, incompatible catheter or damage during return shipping to medtronic for analysis as the device was returned outside of its protective dispenser coil and introducer sheath.The inner diameter of the micro catheter that was used is 0.0165¿ and is therefore, compatible for use with the axium prime coil per ifu: axium prime detachable coils should only be delivered through a micro catheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the axium implant coil was stuck inside the distal part of the microcatheter.Since this was the first coil used and it was not able to reach the aneurysm sac, it was necessary to remove the entire system (microcatheter and implant coil) without complications.The system was repositioned to continue and complete the treatment without further complications.The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 6 mm x 5 mm located in the silviana fork.The patient¿s blood flow was normal.The patient¿s vasculature was normal in tortuosity.There are no images for review.There was damage observed on the distal part of the microcatheter and the distal part of the pushwire.

• 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: 10051669
• Report Number: 2029214-2020-00453
• Device Sequence Number: 16859163
• Product Code: KRD
• UDI-Device Identifier: 00847536008274
• UDI-Public: 00847536008274
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2020

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: 01/22/2021
• Device Model Number: APB-6-15-3D-SS
• Device Lot Number: A585582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 65