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

Model Number	APB-3-8-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil was returned for evaluation inside of a cardboard shipping box and within a sealed plastic bag.The sl 10 microcatheter was not returned as it was discarded.The inner diameter (id) of the sl 10 microcatheter was found to be 0.0165¿ (see attached specifications).Per axium prime coil instructions for use (ifu): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿.During evaluation, the axium prime coil was removed from the sealed plastic bag.The axium prime pushwire was found to be broken in two segments which were not retained together by the release wire.(proximal segment): the pushwire segment was measured and found to be approximately 6.3cm in length.The distal end of the pushwire segment was found to be jagged with a broken release wire extending out.(distal segment): the pushwire segment was measured and found to be approximately 181.7cm in length.A broken release wire was found to be extending out from the broken proximal end for the length of approximately 1.0cm.The pushwire was found to be bent at approximately 123.3cm from the proximal end.The axium prime implant coil was found to be detached from the pushwire within the introducer sheath.The axium prime implant coil appeared to be stretched.Although the axium prime implant coil could not be pushed out from within the introducer sheath, the distal segment of the axium prime pushwire was pulled out from within the introducer sheath.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.All other subassemblies appeared to be normal and no other anomalies were observed.The axium prime coil could not be used for testing with an in-house microcatheter due to its damaged condition.Although the cause for the reported resistance could not be determined, evidence found during analysis showed a bend and a break in the pushwire.It is possible that the pushwire became broken and the implant coil detached during return to medtronic as the customer reported no damages to the axium prime coil at the time of the event.It is likely that the release wire became broken as it made contact with the jagged pushwire edge.The cause for the stretched implant coil could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment of a small unruptured saccular posterior communicating artery aneurysm, measuring 5mmx3.5mm, coil stuck in proximal part of the catheter during the procedure.Yes, the implant coil was push smoothly out from the introducer sheath.There were not any patient symptoms or complications associated with this event.No images available for review.The patient¿s blood flow was normal.The vessel was moderately tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.No patient injury was reported.The catheter was not damaged.The coil was not damaged.Yes, the continuous flush was administered during the procedure.After the axium removed prof.Yoon did additional coil insertion and patient was treated.6f envoy, sl-10 microcatheter, synchro 14 ¿ accessory devices were discarded.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8094917
• Report Number: 2029214-2018-00963
• Device Sequence Number: 13949984
• Product Code: KRD
• UDI-Device Identifier: 00847536021242
• UDI-Public: 00847536021242
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 01/10/2021
• Device Model Number: APB-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: A580252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1