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

Model Number	FC-5-10-3D
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	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received report that an axium framing coil detached prematurely.It was noted that the device was prepared as indicated in the instructions for use.The pushwire was not bent or broken.There was no friction or other difficulty during delivery.The physician did reposition the coil 3 times but did not rotate the pushwire or attempt to detach the coil.Continuous catheter flush was administered during the procedure.The coil was removed from the patient and replaced to complete the procedure.There was no harm or injury to the patient who was undergoing a coil embolization procedure to treat a ruptured saccular posterior communicating artery aneurysm.The aneurysm max diameter was 6.34mm and the neck diameter was 3.65mm.Blood flow and vessel tortuosity were normal.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 there were no detachment attempts (instant detacher or manual method) made.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the pushwire was returned for evaluation within the inner pouch; inside of a biohazard bag and a shipping box.There was no implant coil returned with the pushwire.¿ visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil found intact but stretched.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire; it appeared that the manual detachment was attempted at this location.The ai and coupler tubing was found present and intact; indicative of mechanical detachment was not attempted at this location.Bends were found at 11.0cm to 30.5cm from the proximal end.¿ testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.072mm @ 0.063mm; measured 0.085mm @ 0.127mm; measured 0.094mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00269¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00464 ¿and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ conclusion: based on the analysis performed, the axium prime coil was not confirmed to have "non-detachment" issue as the pushwire was returned with the implant coil already detached.However, the root cause could not be determined.Based on the returned device, there was evidence of manual detachment attempt to detach the coil.The coin was pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.The pushwire was bent at several locations.However, the cause for damage could not be determined.There was no non-conformance to specification identified that led to the reported issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the implant coil was not returned; any contribution of the implant coil to the non-detachment issue could not be determined.Per the axium prime coil instructions for use (ifu): if the coil does not detach after 3 attempts, discard the i.D.(instant detacher) and replace with a new i.D.(instant detacher).Also, in the rare event that the coil does not detach and cannot be removed from the implant delivery pusher, use the following steps for detachment.A.Grip the hypotube approximately 5 cm distal of the positive load indicator at the hypotube break indicator and bend the implant delivery pusher just distal to the hbi 180 degrees.B.Next straighten the pusher back, continue bending and straightening until the pusher tubing opens exposing the release element.C.Gently separate the proximal and distal ends of the open pusher.Then, under fluoroscopy, pull the proximal portion of the implant delivery pusher approximately 2-3 cm to confirm implant detachment 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 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: 12908420
• Report Number: 2029214-2021-01543
• Device Sequence Number: 14454179
• Product Code: KRD
• UDI-Device Identifier: 00847536034174
• UDI-Public: 00847536034174
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162704
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2022

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: 11/12/2023
• Device Model Number: FC-5-10-3D
• Device Catalogue Number: FC-5-10-3D
• Device Lot Number: B116917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 12/03/2021; 01/17/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/21/2021; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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