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

Model Number	APB-5-15-3D-SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event reported in lieu of analysis results.Analysis of the axium prime coil (lot no.B110198) found that the pusher was found bent at ~135.5 cm, 171.0 cm, and 172.0 cm from the proximal end.The axium prime implant coil was found not attached to the pusher.The axium prime implant coil broke off from the pusher from the coil shell weld.In addition, the axium prime implant coil polypropylene filament broke off from the detach element.The axium prime implant coil was found damaged and stretched on its proximal end and had lost its original shape.The axium prime implant coil tip od (outer diameter) was measured to be 0.0109¿ which is within specifications (specification: 0.0112¿ +0.0010¿ / -0.0020¿).Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed.The introducer sheath was not returned; therefore, analysis could not be performed and conformance to specification could not be assessed.There were no reported issue preparing the axium prime coil prior to use (which includes coil hydration).Therefore, it is likely that the implant coil became damaged during preparation or due to an improper hubbing technique (over tight ening of the rhv).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil could not be pushed out of the sheath.The physician felt much resistance when attempting to advance the coil.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for aneurysm embolization.

• 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: 11889976
• Report Number: 2029214-2021-00625
• Device Sequence Number: 11090217
• Product Code: KRD
• UDI-Device Identifier: 00847536032040
• UDI-Public: 00847536032040
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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 Expiration Date: 10/30/2023
• Device Model Number: APB-5-15-3D-SS
• Device Catalogue Number: APB-5-15-3D-SS
• Device Lot Number: B110198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1