MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-4-6-HX-SS
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime pushwire was returned for analysis within a shipping box; within a resealable biohazard pouch; within an open echelon outer carton; within a dispenser coil and within an introducer sheath.The axium prime coil was decontaminated.The axium prime pushwire was found to be bent and kinked within the introducer sheath.The introducer sheath was found inverted on the pushwire with the wavelock at the distal end.No damages or irregularities were found with the introducer sheath.The shield coil was found to be broken with the implant coil already detached and not returned for analysis.The axium prime implant coil tip outer diameter could not be measured as it was not returned.The introducer sheath inner diameter (id) was measured and found to be within specification.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿coil resistance/stuck in sheath¿ could not be confirmed and the cause could not be determined.The axium prime pushwire was returned with the implant coil already detached and therefore could not be used for stuck in sheath testing.The introducer sheath was returned inverted on the pushwire with the wavelock on the distal end.This could potentially contribute to the report of coil resistance/stuck in sheath as this portion of the introducer sheath was designed to create resistance on the proximal end of the pushwire.The pushwire was found bent and kinked, indicative of either high tortuosity or attempts at advancing the pusher against resistance.As the device was returned without its protective dispenser coil, it is also possible that the damage occurred during return shipping to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the axium coil encountered resistance within the protective sheath.The coil hoop was flushed prior to attempting to advance the coil out of the protective sheath.The device was prepared and used per the instructions for use (ifu).There was no patient injury.During the treatment of an unruptured left internal carotid c4 segment aneurysm.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9099329
• Report Number: 2029214-2019-00940
• Device Sequence Number: 2752691
• Product Code: KRD
• UDI-Device Identifier: 00847536008151
• UDI-Public: 00847536008151
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 01/07/2022
• Device Model Number: APB-4-6-HX-SS
• Device Lot Number: A762941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR