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

Model Number	APB-3-8-3D-ES
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the axium coil was observed to be unwinding during the procedure.Prior to the event, the microcatheter was delivered to the lesion through the guide catheter.Then the axium coil was pushed from the microcatheter and the spring coil filling into the tumors.Through the guiding catheter angiography tamponade and found there was something abnormal, and again through the ray, observing the spring coil was unwinding.The spring coil was timely withdrawn out of the body with microcatheter and guiding catheter.Considering the patient's situation, the surgery was suspended.It was noted that there was coil premature detachment.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 5mm x 4mm located in the ophthalmic segment of the internal carotid artery (ica).The patient¿s blood flow was normal and the vasculature was moderate in tortuosity.The pushwire was bent or broken.There was no friction or difficulty during delivery.The physician did not reposition the coil and did not attempt to detach the coil.There was no rotating of the delivery pusher during procedure.A continuous flush was administered during the procedure.
Additional Manufacturer Narrative
D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the axium prime coil was returned for analysis with implant coil detached from the pushwire.The actuator interface was found still securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The axium prime pushwire was found broken at the positive load indicator and between the positive load indicator and break indicator.The segments are retained by the release wire.This is indicative that manual detachment was attempted at these locations.The coin was fully retracted out of the lumen stop.The shield coil was found broken.The implant coil was found damaged and stretched with the polypropylene filament broken.The detach element was broken from the implant coil and was not returned for analysis.The retainer ring was found to be damaged (ovalized) and cannot be accurately measured.Based on the analysis performed, the report of implant coil ¿premature detachment¿ could not be confirmed as the pushwire was found broken and the release wire was retracted, releasing the implant coil as the device is designed to do.The damage to the retainer ring could have contributed towards the customer reported premature detachment.Possible causes for retainer ring damage and confirmed report of ¿coil stretch¿ and ¿pusher kink/damage¿ are manipulation of the device against resistance caused by: lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one to one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance, or incompatible catheter.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BARE 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9598283
• Report Number: 2029214-2020-00049
• Device Sequence Number: 11381134
• Product Code: KRD
• UDI-Device Identifier: 00847536031944
• UDI-Public: 00847536031944
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/15/2020

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: 10/02/2022
• Device Model Number: APB-3-8-3D-ES
• Device Lot Number: A909084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR