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

Model Number	APB-2.5-8-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	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime pushwire was found to be kinked at ~72.3cm and bent at ~126.0cm.The shield coil was found intact with the implant coil found stretched and broken with the polypropylene filament also broken.The axium prime implant coil tip was not returned for analysis therefore the tip outer diameter could not be measured.The introducer sheath id (inner diameter) was measured and found to be 0.0175¿ (0.4445mm) which is within specification.No damages or irregularities were found with the introducer sheath.Resistance testing could not be performed due to the damage.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed.The axium p rime pusher was found bent/kinked and the implant coil was found stretched and broken.There were no reported issues pushing the axium prime implant coil from within the introducer sheath during preparation per ifu.Therefore, it is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv) subsequently causing the implant coil to become stuck.Advancing/retracting the coil against resistance would result in damage to the implant coil and the pusher to become bent/kinked.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the axium coil encountered resistance and did not exit the sheath smoothly, as the device was un able to exit out of sheath.The device was prepared and used per instructions for use (ifu).Based on device analysis, the coil was found to have broken and the tip had separated.

• 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: 10010751
• Report Number: 2029214-2020-00409
• Device Sequence Number: 2793842
• Product Code: KRD
• UDI-Device Identifier: 00847536021068
• UDI-Public: 00847536021068
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/29/2020

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: 01/13/2022
• Device Model Number: APB-2.5-8-HX-ES
• Device Catalogue Number: APB-2.5-8-HX-ES
• Device Lot Number: A766504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1