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

Model Number	APB-6-20-HX-SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the axium coil partially detached / broke within the catheter.At the latest coil was coil number 42.When manipulation in the fistula a short part of the coil broke.A part that detached stayed in the patient without any problems, between the other 41 coils.The other part was stayed within the catheter and it was safely removed.This event was reported to have occurred during the treatment of vertebral fistula.The devices were prepared and used per the instructions for use.The pushwire was not noted to have been damaged.There was no friction or difficulty when delivering the coil.The coil was not repositioned and was not attempted to be detached.The pushwire was not rotated.A continuous flush was used.The blood flow was normal.The anatomy was severe in tortuosity.

• 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: 8768163
• Report Number: 2029214-2019-00689
• Device Sequence Number: 13947465
• Product Code: KRD
• UDI-Device Identifier: 00847536013032
• UDI-Public: 00847536013032
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: 09/26/2021
• Device Model Number: APB-6-20-HX-SS
• Device Lot Number: A714719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention