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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Axium prime coil was returned.The axium prime coil was decontaminated.The axium prime coil returned without the introducer sheath.The axium prime coil pushwire was found to be kinked and broken at break indicator but retained by release wire, bends were also found on the pushwire.The implant coil was found to be detached with the detach element intact.Under the microscope, the coin was not found to be located against the lumen stop, and the shield coil was found to be present.The implant coil was not returned.All other subassemblies appeared to be normal and no other anomalies were observed.No other anomalies were observed.Based on the device analysis and the reported information, the report of ¿coil resistance/stuck in sheath¿ was unable to be confirmed as the axium prime was returned without the implant coil and without the introducer sheath.There were no reported issues pushing the axium prime coil out from within its introducer sheath for hydration.Therefore, it is possible that the implant coil became damaged during return of the implant coil back into the introducer sheath.It is possible insufficient preparation of the axium prime coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.However, exact cause of the coil separation is unknow, as there was no allegation of detachment issue or that a detachment attempt being made.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the coil got stuck inside the introducer sheath.The patient was undergoing surgery to treat an aneurysm located at the posterior communicating artery.It was noted there was no vessel tortuosity.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.There was no kink/damaged observed on the coil.The introducer sheath held vertically when the implant coil was pulled back inside as it was hydrated as indicated in the instructions for use (ifu).

• 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: 9900473
• Report Number: 2029214-2020-00307
• Device Sequence Number: 2437967
• Product Code: KRD
• UDI-Device Identifier: 00847536021020
• UDI-Public: 00847536021020
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 11/14/2020
• Device Model Number: APB-2-8-HX-ES
• Device Lot Number: A557021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR