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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil was returned for analysis.No damages or irregularities were found with the introducer sheath and axium prime pusher.Blood was found within the introducer sheath.The axium prime implant coil was found damaged, stretched, and broken with the polypropylene filament broken.The distal segment of the implant coil was found extending out of the introducer sheath.The axium prime coil could not be used for resistance testing due to the damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the cause could not be determined.The returned axium prime implant coil was found damaged/stretched/broken.It is possible the damage occurred during the attempt to advance/retract the coil into the micro catheter against the reported resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damaged micro catheter or tortuous anatomy.Blood was found within the introducer sheath; therefore, it is possible insufficient continuous flush was used, causing blood to backflow up the micro catheter and into the introducer sheath.As the phenom-17 micro catheter used in the event was not returned for analysis, any contribution of the phenom-17 towards the resistance could not be assessed.The phenom-17 micro catheter is compatible for use with the axium prime coil.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the second coil delivered got stuck 1cm into the hub of the microcatheter, and didn't move when pushed or pulled.The device was then able to be pulled out of the microcatheter once the coil unraveled and was retrieved.The device was replaced which was used without issue.The coil was able to be pushed smoothly from the sheath, and no damage was seen on the coil or microcatheter.The patient was undergoing treatment of an amorphous, ruptured, a-com aneurysm with a max diameter of 4mm and a neck width of 2.5mm.It was noted that the patient's blood flow speed and vessel tortuosity were normal.The devices were prepared as indicated per the ifu.There were no related patient symptoms.Ancillary devices include a fubuki 6f guide catheter, phenom 17 microcatheter, chikai guidewire.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12493503
• Report Number: 2029214-2021-01176
• Device Sequence Number: 1240133
• Product Code: KRD
• UDI-Device Identifier: 00847536021235
• UDI-Public: 00847536021235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• 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): 09/19/2021

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 Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: B056142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2021
• Initial Report FDA Received Date: 09/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1