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

Model Number	APB-3.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime implant coil was returned for analysis within a shipping box and within an opened axium prime outer carton.The axium prime pusher and echelon-10 micro catheter used in the event were not returned.The axium prime implant coil was decontaminated.The introducer sheath was also returned.No damages or irregularities were found with the introducer sheath.The axium prime implant coil was found to be damaged and stretched with the polypropylene filament intact.No other anomalies were observed.The axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition and because the implant coil was already detached from the pusher.Based on the device analysis and reported information, the 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, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.Customer reported the patient vessel tortuosity as normal, continuous flush was used and device was prepared per instruction for use (ifu).The implant coil was found damaged and stretched.It is likely that the damage to the axium prime implant coil occurred during the attempt to push the coil through the micro catheter against the reported resistance.Other possible causes for coil stretch/damage are: lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or incompatible catheter.Since the pusher and the micro catheter used in the event was not returned, any contribution of the pusher and micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.The echelon-10 microcatheter has an inn er diameter of 0.0165¿ which is compatible for use with this axium prime coil per ifu.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil encountered resistance/stuck in the catheter during the coiling treatment.Reported device and any accessory devices were prepared as indicated in the ifu.The catheter was not damaged.The coils were not damaged.No continuous flush was not used in the procedure.The vessel was normal tortuous.No patient injury was reported.Even with the device defect there was no complication in the procedure, normal blood flow and no change.A continuous flush was administered during the procedure.The vessel anatomy was normal in tortuosity.No patient injury reported.No images available.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9581353
• Report Number: 2029214-2020-00040
• Device Sequence Number: 14223007
• Product Code: KRD
• UDI-Device Identifier: 00847536021259
• UDI-Public: 00847536021259
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/13/2020

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: 03/29/2021
• Device Model Number: APB-3.5-6-3D-ES
• Device Lot Number: A621471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1