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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime pusher and introducer sheath were tied up into knots.The axium prime pusher was found bent and kinked throughout the length of the pusher.The introducer sheath was found bent and damaged throughout the length of the introducer sheath.The implant coil was already detached and returned within a piece of surgical cloth.The implant coil was found damaged and stretched with the polypropylene filament intact.The axium prime implant coil could not be used for resistance testing due to its damaged condition.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use and lack of continuous flush during delivery.Customer reported continuous flush was used and the device was prepared as per ifu.As the sl-10 microcatheter used in the event was not returned, any contribution of the micro catheter towards the resistance could not be determined.Th e sl-10 micro catheter has an inner diameter of 0.0165¿ (per stryker website) which is compatible for use with the axium prime coil.The customer report of coil stretched as confirmed and the likely cause was retracting the device against the reported resistance.The implant coil was returned already detached.The pusher was broken, and the release wire and coin were retracted out of the lumen stop, therefore the device detached as intended by the detachment elements.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 experienced resistance in the sl-10 microcatheter.When the coil was removed, it was found that the coil was stretched.It was noted a continuous flush had been used, and a replacement coil was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Additional information received from the representative.The patient was treated for an unruptured bifurcation aneurysm of the middle cerebral artery.The aneurysm max diameter was 4mm and the neck diameter was 2.2mm.Patient vessel tortuosity was normal.

• 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: 10602663
• Report Number: 2029214-2020-00981
• Device Sequence Number: 372955
• Product Code: KRD
• UDI-Device Identifier: 00847536032125
• UDI-Public: 00847536032125
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 01/02/2023
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: A953790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1