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

Model Number	QC-2-4-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after the microcatheter and intracranial support catheter were in place, a qc-3-6-3d was filled fir st.Them it was found a qc-2-4-3d could not enter the microcatheter due to resistance in the sheath.A replacement coil of the same model was used, and it passed smoothly.The procedure was then completed with no further issue reported.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 anterior communicating (acom) artery with a max diameter of 4 mm and a 3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.Additional information received reported that during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium coil was returned for analysis within a shipping box, within a plastic bio-pouch, and within a dispenser coil.Visual inspection/damage location details: the axium pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.The axium coil was returned with the introducer sheath correctly assembled on the pusher with the wave lock at the proximal end.No damages were found with the introducer sheath.The axium implant coil was found to be already detached from the pusher.The implant coil was not returned.The pusher was removed from within the introducer sheath.The axium pusher was found bent and broken at ~44.6cm from the pusher distal end with the release wire pulled for 1.5mm.The shield coil was removed, the release wire tip was not extending from the pusher distal end.The release wire coin was found pulled back from the lumen stop.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in sheath¿ report could not be confirmed.There were no reported issue preparing the axium coil prior to use (which includes coil hydration).Therefore, it is possible that the implant coil became damaged during preparation or due to an improper hubbing technique (over tightening of the rhv).However, as the implant coil was not returned any contributing factors could not be assessed and the root cause for the resistance could not be determined.Regarding the detachment of the implant coil, it is likely the damage to the pusher contributed to the event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM 3D
• 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: 12502470
• Report Number: 2029214-2021-01181
• Device Sequence Number: 3596977
• Product Code: KRD
• UDI-Device Identifier: 00847536017399
• UDI-Public: 00847536017399
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: 02/11/2022
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: A781748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR