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

Model Number	APB-5-15-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received in a condition that was contradictory to the complaint description.The axium prime pusher was returned for analysis within a shipping box; within an opened axium prime outer carton; without a dispenser coil and without an introducer sheath.The axium prime pusher was decontaminated.The actuator interface was found loose on the coupler tube.The coin was found retracted out of the lumen stop and resting within the skive area.The shield coil was intact, and the implant coil was already detached and not returned for analysis.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 as the device was already detached.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.Customer reported the patient vessel tortuosity as normal and device was prepared and flushed per instruction for use (ifu).There was evidence that the device was detached using an instant detacher and the implant coil was detached as intended based on the returned product.The inner diameter of the echelon-10 micro catheter is reported as 0.0165¿ and is therefore, compatible for use with the axium prime coil: 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.There is no indication that the event is related to a manufacturing issue, therefore a dhr review is not required.Linked with mdr: 2029214-2020-00110.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment these all five coils were placed on the microcatheter and coils did not pass through so making impossible to embolized the aneurysm.The patient underwent coiling treatment for an unruptured aneurysm.There were not any patient symptoms or complications associated with this event.No medical or surgical intervention needed to prevent a permanent impairment of a function.The vessel was normal tortuous.No patient injury was reported.The event did not lead to or extend patient hospitalization.No images available for review.Yes, the catheter was flushed as indicated per the ifu.Reported device and any accessory devices were prepared as indicated in the ifu.

• 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: 9688689
• Report Number: 2029214-2020-00129
• Device Sequence Number: 19701784
• Product Code: KRD
• UDI-Device Identifier: 00847536008212
• UDI-Public: 00847536008212
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/10/2020

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: 12/14/2019
• Device Model Number: APB-5-15-3D-SS
• Device Lot Number: A389907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1