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

Model Number	APB-1-2-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil would not detach with the instant detacher or manual detachment method.The patient was undergoing surgery for treatment of an arteriovenous malformation or arteriovenous fistula in the eloquent area of the brain.It was noted the patient's blood flow was normal and vessel tortuosity was severe.It was reported that the transarterial embolization (tae) was performed for d-arteriovenous fistula (avf).Coil embolization was performed via headwayduo from distal feeder of occipital artery (oa).The reported product was inserted as the 6th one.The detachment was attempted with id-1 twice, but it failed.The break indicator was bent to try to perform the detachment, but, it failed.An attempt was made to retrieve the device without any action, but it was detached halfway in the microcatheter.The device was retrieved together with microcatheter.There is no patient injury.The procedure was continued without any action, and it was completed safely.Ancillary devices include a headway duo microcatheter.
Additional Manufacturer Narrative
The axium prime coil was returned with the microvention headway duo micro catheter.The axium prime coil was returned outside the headway duo micro catheter.The axium prime coil and headway duo micro catheter were decontaminated.The actuator interface was found bent at the proximal end.The actuator interface was found loose from within the coupler tube.This indicates that the id was used to engaged or pulled on the ai.The pusher was found broken into two segments at the at the load indicator, and not at the manual detachment location (via hypotube), with the remaining portion of the release wire extending out ~3.0cm from the pushwire distal broken end.The break indicator and pusher tack welds were found intact.Under the microscope, the coin was found against the lumen stop and the shield coil was found intact.The implant coil was found detached and missing.The shield coil was stretched, and the release wire tip was found protruding from the pusher distal end which is within specification.The retainer ring appears to be in good condition.For further examination of the coin, the outer shrink tubing was removed.Dried red residue (likely blood) was found on the coin at the lumen stop.The pusher was placed in the sonic cleaner to remove the dried residue.The coin appears to be in good condition.As the pusher was broken into two segments the device could not be used with an in-house id.Therefore, the pusher was broken at the manual detachment location (via hypotube).Difficulty was encountered pulling the release wire out from within the pusher.The distal pusher and release wire became bent; however, the coin did not pull back from the lumen stop.This likely indicates that the coin is jammed at the lumen stop.Using tweezers, an accessible portion of the release wire was pulled causing the coin to pull out from the lumen stop.The lumen stop appears to be in good condition.The lumen stop id was measured to be which is within specification.The release wire coin was found bent and damaged; therefore, the coin width could not be measured.The headway duo micro catheter was examined.No damages were found with the hub.No bends or kinks were found with the catheter body.No damages were found with the distal marker/tip.The headway duo micro catheter was flushed, and water exited from the distal tip.An in-house mandrel was inserted through the headway duo micro catheter without issue.The detached implant coil was not found with the headway duo micro catheter.No other anomalies were observed.The headway duo micro catheter will be sent to the manufacturer.Based on the device analysis and reported information, the report of ¿premature detach from non-detach¿ was confirmed.The implant coil was found detached and not returned.Therefore, any contributing factors from the implant coil could not be assessed.It is likely that the jammed condition of the coin in the lumen stop led to the difficulty during detachment both during the event as well as during testing; however, the cause for the coin ¿jamming¿ could not be determined.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 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: 9379063
• Report Number: 2029214-2019-01171
• Device Sequence Number: 16914081
• Product Code: KRD
• UDI-Device Identifier: 00847536021112
• UDI-Public: 00847536021112
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/11/2020

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 Model Number: APB-1-2-3D-ES
• Device Catalogue Number: APB-1-2-3D-ES
• Device Lot Number: A866279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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