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

Model Number	PC-2-6-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
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 there was coil non-detachment.Since the device could not be deployed during the operation, the operation was performed again with the replacement of spare parts.The physician attempted to detach the coil with the instant detacher more than 3 times.The physician did not try to detach with another instant detacher.There was a manual attempt at detachment via hypotube, more than 3 times.  there was no issue with the instant detacher.No patient symptoms or further complications were reported as a result of this event.The reported device and any accessory devices were prepared as indicated in the ifu.  the patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the anterior communicating artery with a max diameter of 4.5mm and a 2.5mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition- the concerto coil was returned for analysis within a shipping box, within an unsealed plastic biohazard pouch; within an opened axium inner pouch and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found loose within the coupler tube.This is indicative of detachment attempts using an instant detacher at this location.The break indicator was found intact.There is no evidence of manual detachment at this location.No damages or irregularities were found with the rest of the pusher.The coin was found still against the lumen stop.Blood was found under the ptfe shrink tubing, on the coin and within the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.No damages were found with the implant coil.Testing/analysis ¿ the concerto implant coil failed to detach using an in-house instant detacher or by breaking the break indicator and retracting the release wire as the release wire was found stuck.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved.The release wire was retracted, and the coin exited the lumen stop with no issues and no resistance encountered.No other damages or anomalies were found with the returned device.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachment is the blood found within the lumen stop and under the ptfe shrink tubing causing the coin to become stuck within the lumen stop.H6.Coding updated based on analysis results.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 PGLA HLX
• 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: 13573128
• Report Number: 2029214-2022-00249
• Device Sequence Number: 5912554
• Product Code: KRD
• UDI-Device Identifier: 00847536032972
• UDI-Public: 00847536032972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022

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: 04/26/2024
• Device Model Number: PC-2-6-HELIX
• Device Catalogue Number: PC-2-6-HELIX
• Device Lot Number: B196968
• 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: 02/17/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: 47 YR
• Patient Sex: Male