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

Model Number	QC-3-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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 after the coil was deployed, it could not be detached.Two detachment attempts had been made with the instant detacher, one attempt was made with a second instant detacher, and no manual detachment attempts were made.It was stated there was no issue with the instant detachers.A replacement coil was used to complete 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 an unspecified aneurysm with a minimal vessel tortuosity.Ancillary devices include an echelon 10 microcatheter, synchro 2 guidewire.
Additional Manufacturer Narrative
H3: analysis of the axium implant coil (lot no.B094282) found that the coil was still attached the pushwire.The coin appeared located against the lumen stop.The shield coil was present and intact.The break indicator at the manual detachment location was found present and intact; indicative of manual detachment was not attempted at this location.The ai and coupler tubing were present and intact; indicative of mechanical detachment was not attempted.No bend was found on the pushwire.No damage was found with the implant coil.An in-house instant detacher was then used for a detachment attempt.The axium implant coil successfully detached from the pushwire within 1 attempt.All other subassemblies appeared to be normal.No other anomalies were observed.Based on the analysis performed, the axium coil was confirmed to have "non-detachment" issue as the returned axium coil was still attached to the pushwire.However, the root cause could not be determined as no damages were found with the returned axium coil.In addition, there were no attempts to detach the coil via the mechanical or manual detachment methods.An in-house instant detacher was used for a detachment attempt.The axium implant coil successfully detached from the pushwire within 1 attempt using an in-house instant detachment.H6: method code updated to b01.Result code updated to c07.Conclusion code updated to d15.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 HELIX
• 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: 11759868
• Report Number: 2029214-2021-00519
• Device Sequence Number: 3724642
• Product Code: KRD
• UDI-Device Identifier: 00847536029569
• UDI-Public: 00847536029569
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 09/30/2023
• Device Model Number: QC-3-8-HELIX
• Device Catalogue Number: QC-3-8-HELIX
• Device Lot Number: B094282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR