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

Model Number	QC-3-10-3D
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is reportable for analysis results.The pushwire was found to be bent at 11.5cm from the proximal end.In addition, the pushwire also found to be broken at 3.0cm from the proximal end.The implant coil was found to be stretched with the polypropylene filament intact.Based on the device analysis and reported information, axium coil was confirmed to have ¿product damaged/deformed out of package" as the returned coil was found to be stretched.In addition, the pushwire was bent and broken at the proximal end.However, the cause for damages could not be determined.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil pushwire was bent when it was taken out of the coil hoop.A replacement product was used in the procedure.There was no patient involvement with the event.Additional information received reported the device packaging was intact with no visible damage.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.The damage was noticed during device prep.The physician observed the damage on the proximal wire as the black rubber stopper was about to be removed.

• 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: 12086619
• Report Number: 2029214-2021-00788
• Device Sequence Number: 17010685
• Product Code: KRD
• UDI-Device Identifier: 00847536029903
• UDI-Public: 00847536029903
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 12/09/2023
• Device Model Number: QC-3-10-3D
• Device Catalogue Number: QC-3-10-3D
• Device Lot Number: B129847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• 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