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

Model Number	QC-2.5-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
He axium coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.No bends or kinks were found with the axium pusher.No damages were found with the introducer sheath.The axium pusher was found broken within the introducer sheath at ~143.4cm from the pusher¿s proximal end (pusher total length specification: 188.0cm ± 1.5).The pusher was removed from within the introducer sheath with ~42.7cm of what appears to be the pusher¿s release wire remaining within the introducer sheath.When compared to the product drawing, ~44.6cm of the axium pusher was not returned.In addition, the axium implant coil was not returned.The id (inner diameter) of the introducer sheath was measured to be 0.0185" (0.47mm) which is within specifications (specification: 0.47mm +0.03/-0.00).Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed and the cause could not be determined.There were no reported issue preparing the axium coil prior to use.Therefore, it is possible that the implant coil became damaged during preparation subsequently causing resistance within the introducer sheath.However, the axium implant coil was not returned; the before, analysis could not be performed and conformance to specification could not be assessed.Regarding the pusher separation, based on the appearance of the separated end, it is possible that the separation occurred as a result of advancing the pusher against resistance causing the pusher to bend and subsequently break during manipulations.It appears excessive force was used.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil had a large push resistance in the sheath and couldn't be pushed out.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the posterior communicating artery.The max diameter was 2.7mm, and the neck diameter was 1.9mm.The patient¿s blood flow was normal, and the vessel tortuosity was minimal.Ancillary devices include a cook 5f sheath.Additional information received indicated the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• 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: 12088505
• Report Number: 2029214-2021-00790
• Device Sequence Number: 3465537
• Product Code: KRD
• UDI-Device Identifier: 00847536029859
• UDI-Public: 00847536029859
• 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): 06/29/2021

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: 02/18/2023
• Device Model Number: QC-2.5-6-3D
• Device Catalogue Number: QC-2.5-6-3D
• Device Lot Number: A979287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR