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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.¿ therefore, the echelon-10 micro catheter was found to be compatible for use with the axium prime coils the axium prime coil pushwire was found to be bent at ~6.2cm, kinked at ~34.9cm, ~84.3cm and broken with the release wire intact at ~139.7cm from proximal end.In addition, the axium prime coil was found to be missing from the pushwire but returned.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.The returned segment of implant coil was found to be stretched and damaged.All other subassemblies appeared to be normal and no other anomalies were observed.The implant coil could not be used for resistance testing with the returned echelon micro catheter due to its damaged condition.The implant coil was found to be detached.The implant coil was returned and found to be stretched and damaged.It is likely that the damages to the axium prime coil and pushwire occurred during the attempt to push the coils through the echelon-10 micro catheter against the reported resistance.(pli-30) no issues were found with the returned echelon-10 hub or catheter body.No bends or kinks were found with the distal tip.In addition, no resistance or difficulties were encountered when passing an in-house axium coil through the echelon-10 micro catheter.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the returned axium prime coil could not be used for resistance testing with the returned (pli-30) echelon-10 micro catheter due to its damaged condition.However, no resistance or difficulties were encountered when passing an in-house axium coil through the echelon-10 micro catheter.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, and lack of continuous flush during delivery.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 ruptured saccular aneurysm located in anterior communicating artery, measuring 4mmx2mm, these both coils felt resistance while pushing inside the hub of the microcatheter.Even there was a resistance when preparing coils according to ifu.There was also slight resistance when the coils were pushed from the introducer sheath.The patient was ultimately treated with other axium coils.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 normal tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.A continuous flush was maintained through the procedure.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8504043
• Report Number: 2029214-2019-00335
• Device Sequence Number: 16510427
• Product Code: KRD
• UDI-Device Identifier: 00847536021891
• UDI-Public: 00847536021891
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/11/2019

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: 03/26/2019
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: A250250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1