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

Model Number	APB-6-20-3D-SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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Medtronic received a report that the axium coil broke while being withdrawn.The microcatheter was placed in the aneurysm for coil deployment.The coil was introduced, flushed and pushed in the microcatheter.At the time of delivery aneurysm resistance was observed and coil was withdrawn with the help of the micro catheter.It was noted that there was friction/difficulty during delivery.Continuous flush was administered during the procedure.No patient symptoms or complications were associated with this event.The patient was being treated for an unruptured aneurysm in the left ica suprclinoid.The morphology was amorphous with a max diameter of 6 mm and a neck diameter of 4 mm.The patient had normal blood flow and the vessel tortuosity was moderate.
Additional Manufacturer Narrative
Product analysis #(b)(4) as found condition: two axium prime coils were returned for analysis within a shipping box and within an opened axium prime outer carton.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: (coil 1) the actuator interface was found securely attached to the coupler tube.No evidence of detachment attempts was found at this location using an instant detache.The break indicator was found intact.No evidence of manual detachment attempts was found at this location.No damages or irregularities were found with the axium prime pusher.The coin was found still against the lumen stop.The shield coil was found intact and the detach element was found still attached to the pusher.The axium prime implant coil was found broken from the detach element.The implant coil was found damaged, stretched and broken with the polypropylene filament also broken.(coil2) the actuator interface was fully retracted out of the coupler tube with the two segments retained by the release wire.No other damages were found with the pusher.The shield coil was found still intact with the implant coil already detached and not returned for analysis.It is likely this pusher belongs to the device used to replaced the complaint unit.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil separation/break¿ was confirmed.Possible causes of failure are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or user advances the coil against resistance.Customer reported vessel tortuosity was moderate, and friction/difficulty was encountered.The cause of the friction could not be determined.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the coil break could not be determined.The coil was found stretched/damaged/broken.It is likely the damages found occurred due to advancing/retracting the implant coil against the reported resistance.There is no indication that the event is related to a potential manufacturing issue.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.
Event or Problem Description
Additional information was received and it was reported the resistance was in the distal part of the catheter.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12227989
• Report Number: 2029214-2021-00924
• Device Sequence Number: 3509058
• Product Code: KRD
• UDI-Device Identifier: 00847536032071
• UDI-Public: 00847536032071
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2021

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: 02/15/2024
• Device Model Number: APB-6-20-3D-SS
• Device Catalogue Number: APB-6-20-3D-SS
• Device Lot Number: B161619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 09/26/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1