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

Model Number	QC-2-8-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium pushwire was kinked and the axium coil was found prematurely detached.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the posterior communicating artery of the right internal carotid artery (ica) with a max diameter of 6.2 mm and a 4.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that when the qc-2-8-helix detachable spring coil was just taken out of the package outside the body, the delivery rod was found to be kinked.The surgeon tried to push the spring coil outside the body and found that the spring coil had detached itself.The surgeon believed that this was a product quality problem and required it to be returned for identification.It was reported the pusher was kinked/broken.There was no friction or difficulty during testing or delivery.The continuous flush was administered during the procedure.The damage was located on the distal section of the pushwire.It was reported coil separation/break/premature detachment occurred.The coil was not implanted, the coil separated early when trying to push outside the body.There was no surgical or medicinal intervention required.The pushwire was bent or broken.This was not done on purpose.There was no friction or difficulty during delivery.The physician did not reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher 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.
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 that the cause of the pusher kink was not determined.There were no issues that resulted in the damage that was found, kinking was found when taking it out.
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 (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a sealed tyvek biohazard pouch and within a dispenser track.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be broken but retained by release wire at 145.0cm from proximal end.The coin was found to be not against the lumen stop.The implant coil was already detached and not returned.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium prime was returned with the implant already detached; however, the cause could not be determined.Since the implant coil and included detach element were not returned for analysis, any contributing factors could not be determined.A possible cause for premature detachment is pushwire damage.The customer reported pushwire kink when removed from package.It is likely pushwire break occurred during removal from introducer sheath.However, root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was confirmed as the pushwire was found to be returned damaged, not secured within the rubber stopper.It is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was confirmed.Pushwire damage can occur if the user advances the device against resistance.However, there was not any fric tion or difficulty during testing or delivery.Therefore, the cause for the pushwire kink could not be confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received stating that there was no damage or evidence of tampering to the device packaging.It was unknown if the proximal end of the pushwire was secured in the guidewire clip when the package was opened.The damage was noticed upon opening the package and taking out the spring coil, that is when the damaged push rod was noticed.There was no preparation performed prior to the damage being noticed.
Additional Manufacturer Narrative
H3: analysis of the device is currently in-progress, but has not been completed at the time of this report.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: 18552531
• Report Number: 9612164-2024-00349
• Device Sequence Number: 20758074
• Product Code: KRD
• UDI-Device Identifier: 00847536037304
• UDI-Public: 00847536037304
• 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,Followup
• Report Date (Section B): 04/11/2024

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: 01/05/2025
• Device Model Number: QC-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: 223568999
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 01/18/2024; 02/26/2024; 03/20/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/18/2024; 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female