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

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	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium pushwire (model: qc-2-4-3d lot: b008710) was returned for analysis within a shipping box; within a plastic biohazard pouch; and within a dispenser coil.The axium pushwire was returned without the introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The axium pushwire was found to be bent at ~74.2cm, ~114.0cm and ~156.5cm from proximal end.The axium implant coil appeared to be detached and not returned.No other anomalies were observed.Based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be c onfirmed as the introducer sheath and implant coil were not returned and the root cause could not be determined.Regarding the damage to the axium pushwire, as the issue was not reported by the customer, it is possible the damage occurred during return to medtronic for evaluation.The review of lot history records shows that the finished device has met all manufacturing requirements and specif ications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the one axium was found to be stretched after being pushed out of the protective sheath and another could not be pushed out of the protective sheath.It was reported that the spring coil was taken out of the package, pushed out of the protective sheath and found to be stretched.Another coil was opened but was unable to be pushed out of the protective sheath.It was replaced with another spring coil to complete the surgery.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 a ruptured, saccular aneurysm located in the c6 segment of the left internal cervical artery.The max diameter was 2 mm.The neck diameter was 1.5 mm.The patient¿s blood flow and vessel tortuosity were normal.Additional information received reported that the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11164800
• Report Number: 2029214-2021-00044
• Device Sequence Number: 3501837
• Product Code: KRD
• UDI-Device Identifier: 00847536029811
• UDI-Public: 00847536029811
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 04/14/2023
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: B008710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2021
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR