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

Model Number	APB-3-10-HX-ES
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the during a coil replacement, there was early highlight, and coil was lost inside the patient's "vase." it was clarified that the following occurred: coil separation/break/premature detachment.The coil remained in the patient and was not implanted at the intended location.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did reposition the coil but did not attempt to detach it.Continuous flush was administered during the procedure.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.This event resulted in no injury to the patient.

• 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: 9570823
• Report Number: 2029214-2020-00023
• Device Sequence Number: 1953934
• Product Code: KRD
• UDI-Device Identifier: 00847536021105
• UDI-Public: 00847536021105
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2021
• Device Model Number: APB-3-10-HX-ES
• Device Catalogue Number: APB-3-10-HX-ES
• Device Lot Number: A714962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60