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

Model Number	APB-6-20-3D-SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2020
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 report that axium coil broke during delivery into the aneurysm.During the treatment of a posterior circulation dissection aneurysm, the surgeon half-deployed the lvis.The echelon catheter was in place and the axium prime coil (6-20) was used to form a basket, when preparing to adjust the coil to push back the guidewire, it was revealed through the angiography that the coil had broken halfway in the aneurysm and halfway in the tube.The surgeon was then able to insert the broken part of the coil into the dissecting aneurysm with a guidewire.Part of the withdrawn coil and pushwire will be returned to for analysis.The coil was placed within the intended location.No additional medical intervention was required for this event.The pushwire was not broken and will be returned for analysis.There was no friction when the coil was advanced.The coil was only repositioned one time.The coil was not attempted to be detached.The devices were prepared and used per the instructions for use (ifu).The customer was notified to return the device for analysis.No patient injury occurred.There are no images.The patient was being treated for a basilar artery dissection aneurysm that was unruptured.The max diameter was 8 mm and the neck was 6 mm.The blood flow was low.The vessel anatomy was minimal in vessel tortuosity.
Additional Manufacturer Narrative
The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.There is no evidence of any detachment attempts by mechanical or manual methods.The axium prime pusher was found kinked at ~41.2cm from the distal end.The coin was present and against the lumen stop.The shield coil was found intact.The implant coil was already detached and not returned for analysis.Customer reported the implant coil was implanted and left within the patient.The shield coil was removed; and the release wire was found still extending out of the retainer ring ~0.003¿ which is within specification (specification: 0.002¿ ¿ 0.005¿).The retainer ring was found damaged (ovalized) and the inner diameter could not be reliably measured.No other damages or anomalies were found.Based on the device analysis and reported information, the customer¿s report of ¿coil separation/break¿ was not confirmed, however a premature detachment was found and is likely the failure reported.There was no evidence of any detachment attempts.The likely cause of the non-detachment is the damage found on the retainer ring, causing the detach element to slip out.Potential causes for damage to retainer ring are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coils not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance, and incompatible catheter.Customer reported no friction when inserting the coil, device was repositioned once, the device was prepared per ifu and patient vessel as minimal.There is no malfunction with the pusher release wire that would contribute towards the premature detachment.As the implant coil and echelon-10 micro catheter used in the event were not returned, any contribution of the implant coil or micro catheter to the issue could not be determined.The echelon-10 has an inner diameter of 0.0165¿ which is compatible for use with the axium prime coil per ifu.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: 10248260
• Report Number: 2029214-2020-00670
• Device Sequence Number: 3401377
• Product Code: KRD
• UDI-Device Identifier: 00847536032071
• UDI-Public: 00847536032071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 08/23/2022
• Device Model Number: APB-6-20-3D-SS
• Device Catalogue Number: APB-6-20-3D-SS
• Device Lot Number: A887983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR