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

Model Number	QC-2-4-HELIX
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received a report regarding an axium coil that had prematurely detached, stretched, and separated/broke.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the right cavernous sinus with a max diameter of 12.8 mm and a 8.9 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the surgeon performed aneurysm embolization.After the microcatheter was in place, the coils were filled.After 8 coils were placed, the qc-2-4-helix coil was selected for filling.Position adjustment was required during embolization.The coil was stretched during the re-retrieval adjustment process and could not be fully retracted into the microcatheter.Then when withdrew the coil, push guide wire and microcatheter as a whole, confirmed that the coil had accidentally detached and remained in the parent vessel.Finally, the surgeon used a stent to press the coil to avoid excessive exposure of the coil in the blood vessel.The surgeon believed that this was a product quality problem and requested to return it, please identify it.It was reported coil separation/break/premature detachment occurred.The implant coil remains in the patient.The coil was not implanted in the intended location.The action/treatment plan used to secure the coil was fixing the spring coil body with a stent.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction to difficulty during delivery.The physician did reposition the coil two times.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include an echelon 10 microcatheter.
Event or Problem Description
Additional information was received that there were no issues noted that resulted in the damage that was found.
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.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium coil was returned for evaluation inside of a biohazard bag and a shipping box.Visual inspection/damage location details: the implant coil was still attached to the pushwire.The coin was located against the lumen stop.The break indicator, ai and coupler tubing were found intact.The implant coil appeared to be severely stretched; with the polypropylene broken.No bend was found on the pushwire.Testing/analysis: n/a.Conclusion: based on the device analysis and reported information, the customer¿s report of "premature detachment" was not confirmed as the returned coil was still attached to the pushwire.However, the customer report of ¿coil stretch¿ and "coil separation/break" were confirmed as the returned coil was found severely stretched with the polypropylene broken.The cause for damages could not be determined.Possible causes include vessel tortuosity, resistance during delivery, difficulty navigation, and re-positioning.Per our instructions for use (ifu): ¿handle the axium detachable coil with care to avoid damage before or during treatment.If the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been stretched and could possibly break.Gently remove and discard both the catheter and coil." 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
• 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: 16087398
• Report Number: 9612164-2023-00034
• Device Sequence Number: 2034186
• Product Code: KRD
• UDI-Device Identifier: 00847536037281
• UDI-Public: 00847536037281
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2023

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: 01/24/2025
• Device Model Number: QC-2-4-HELIX
• Device Catalogue Number: QC-2-4-HELIX
• Device Lot Number: 223667211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 01/06/2023; 02/24/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/13/2023; 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male