MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	FC-3-6-3D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coil prematurely detached while coiling the aneurysm.A fc 3x6 coil was being repositioned and the coil detached.About 4cm of the coil was in the xt-17 microcatheter.The physician pulled (b)(6) on teh microcatheter and pulled out the microcatheter with the coil inside.No surgical or medicinal intervention was required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician repositioned the coil four times.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during procedure.A continuous flush was administered during the procedure.The patient was undergoing surgery for treatment of a saccular, unruptured pericallosal aneurysm with a max diameter of 3.5mm and a 3.4mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.Ancillary devices include a stryker xt-17 microcatheter and a synchro select soft guidewire.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3: an axium prime coil and a non-medtronic stryker xt17 catheter were returned for analysis.The stryker xt17 micro catheter has a labeled id (inner diameter) of 0.017".Per axium prime coil instructions for use (ifu): ¿axium prime coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿.Therefore, the stryker xt17 micro catheter was found to be compatible for use with the axium prime coil.The axium prime coil was returned without introducer sheath.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be bent at ~7.5cm, kinked at ~153.6cm, and bent at ~154.7cm from proximal end.The coin was found to be still against the lumen stop.The implant coil was already detached and not returned.No other anomalies were observed.The stryker xt 17 catheter total length was measured to be ~156.5cm.The useable length was measured to be ~150.2cm.No damages were found with the hub; however, blood residue was found within hub.No bends or kinks were found with the catheter body.No damages were found with the distal tip.Under the microscope, the outer jacket was then removed to gain access to the coin.The coin appeared to be damaged and appeared to have blood residue.The coin was measured to be 0.096mm at 0.063mm which is not within specification, 0.095mm at 0.127mm, and 0.096mm at 0.275mm which were within specification.The lumen stop was found to be visually acceptable.The retainer ring was found to be visually acceptable and measured to be 0.0049¿ which is not within specification.Based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium prime was returned with the implant already detached; however, the cause could not be determined.The customer reported no manual detachment of implant were attempted.Since the implant coil and included detach element were not returned for analysis, any contributing factors could not be determined.A possible cause for premature detachment is the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.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.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 FRAMING COIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12833505
• Report Number: 2029214-2021-01495
• Device Sequence Number: 19921717
• Product Code: KRD
• UDI-Device Identifier: 00847536034051
• UDI-Public: 00847536034051
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 06/04/2023
• Device Model Number: FC-3-6-3D
• Device Catalogue Number: FC-3-6-3D
• Device Lot Number: B035062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female