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 Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
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 aneurysm was coiling with/without angioplasty.The coil was deployed in the microcatheter, however, the coil separated/broke/prematurely detached.The coil was removed inside of the microcatheter.The patient was undergoing surgery for treatment of a saccular aneurysm with a max diameter of 3mm and a 1mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the aneurysm was coiling with/without angioplasty.The coil was deployed in the microcatheter, however, the coil separated/broke/prematurely detached.The coil was removed inside of the microcatheter.No medical/surgical intervention was required it was unknown if the pushwire was broken or bent.It was unknown if there was any friction or difficulty during the delivery.It was unknown if the physician repositioned the coil.It was unknown if the physician attempted to detach the coil.It was unknown if the physician rotated the delivery pusher during the procedure.A continuous flush was administered during the procedure.The device and any accessory devices were prepared per the ifu.No patient symptoms or complications were associated with this event.The product was replaced with a medtronic product.Ancillary devices include a microcatheter.
Additional Manufacturer Narrative
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 received reported that 2-3 detachment attempts were made with the instant detacher and 2-3 times with manual method.The catheter was discarded.
Additional Manufacturer Narrative
H3: the axium prime pusher was returned for analysis within a shipping box; within an opened axium prime outer carton; within a resealable plastic biohazard pouch and within an introducer sheath.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.No evidence of detachment attempts using an instant detacher at this location was found.The pusher was found broken at the break indicator with the two segments retained by the release wire.The coin was found retracted out of the lumen stop.The shield coil was found stretched and entangled with the release wire.The implant coil was already detached and not returned for analysis conclusion: based on the analysis performed, the customer report of ¿premature detachment" and ¿coil separation/break¿ could not be confirmed.The axium prime pusher was found broken at the break indicator, indicative that a manual detachment was attempted at this location.The release wire was found retracted and the coin was pulled out of the lumen stop, detaching the implant coil as intended by the detachment elements.In addition, customer reported 2-3 detachment attempts were made with the instant detacher and 2-3 manual detachment attempts.Therefore, premature detachment could not be confirmed.As the implant coil used in the event was not returned for analysis, any contribution of the implant coil towards the reported premature detachment could not be determined.There was 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.

• 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: 12619106
• Report Number: 2029214-2021-01266
• Device Sequence Number: 4038692
• Product Code: KRD
• UDI-Device Identifier: 00847536038615
• UDI-Public: 00847536038615
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2022

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: 02/11/2024
• Device Model Number: FC-3-6-3D
• Device Catalogue Number: FC-3-6-3D
• Device Lot Number: 221125628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 12/17/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/08/2021; 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG