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

Model Number QC-3-8-3D

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/09/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the qc-7-30-3d coil was automatically detached, and part of the coil was in the blood vessel.Then a qc-3-8-3d was used for filling.During the filling process, it was found the coil was automatically detached.The pushwire was pulled out, and part of the coil was in the vascular cavity.One sab-6-30 was implanted to press the two coils against the side wall of the vessel.There was no damage to the pushwires, no resistance experienced during deliver, no detachment attempts made, no repositioning or rotation of the pushwire, and a continuous flush had been administered during the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right posterior communicating (pcom) artery c7 with a max diameter of 7.5 mm and a 4 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.

Event Description

Additional information received reported that the coils and solitaire ab remain in the right a1 and a2 blood vessels.There were no problems with the qc-7-30-3d pushwire.

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.

Manufacturer Narrative

H3.Product analysis findings: the implant coil appeared to be detached from the pushwire.The shield coil was present and no damage.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the break indicator (manual detachment location); it appeared that the manual detachment was attempted at this location.The ai and coupler tubing were present and intact.The pushwire was found to be bent at 15.0cm to 24.0cm from the proximal end.In addition, the pushwire was also found to be kinked at 3.5cm from the proximal end.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.076mm @ 0.063mm; measured 0.087mm @ 0.127mm; measured 0.099mm @ 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 0.00270¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00460 ¿and found to be within specification.All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the axium coil was confirmed to have "premature detachment" issue as the pushwire was returned with the implant coil already detached.The root cause could not be determined.Based on the returned device, there was evidence of manual detachment attempt to detach the coil as the pusher was also found to be broken at the manual detachment location; with the coin 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 non-detachment 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 and detached element were not returned; any contribution of the implant coil and detached element to the premature detachment issue could not be determined.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 3D
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11805135
• MDR Text Key: 249972337
• Report Number: 2029214-2021-00553
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536029897
• UDI-Public: 00847536029897
• Combination Product (y/n): N
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: QC-3-8-3D
• Device Catalogue Number: QC-3-8-3D
• Device Lot Number: B063584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Manufacturer Received: 05/09/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 05/20/2021; 08/01/2021
• Supplement Dates FDA Received: 06/09/2021; 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 55