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

Model Number APB-4-10-HX-SS

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the 4x10 axium coil was inserted, but then removed as it was not coiling in the desired location within the aneurysm.The echelon microcatheter tip position was then changed, and the coil was re-inserted and successfully detached.The next coil used was stiff to push, and the continuous flush wasn't running.After a pause, it was noticed the pushwire marker from the 4x10 coil was still on the screen despite having been removed.It was discovered the distal half of the pushwire had snapped free from the proximal half, and was lodged in the echelon.The pushwire segment was then successfully retrieved.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.The patient was undergoing surgery for treatment of an aneurysm with normal vessel tortuosity.Additional information was received reporting that the coil was implanted at the intended location.On follow-up, the physician clarified that only the proximal end of the pushwire was retrieved, the distal end of the pushwire remained implanted in the patient.It was noted that despite the issue, the procedure was considered to be completed successfully and without any harm to the patient.

Manufacturer Narrative

H6.Coding updated regarding analysis results.Product analysis: the axium prime pusher (model: apb-4-10-hx-ss, lot: a545554) and microcatheter were returned for analysis within a shipping box; within two sealed biohazard pouches and without a dispenser coil or introducer sheath.Only the distal ~43.6cm segment of the axium prime pusher was returned.The proximal segment and release wire were not returned for analysis.However, the customer reported the distal end of the pusher remained within the patient and the proximal was shipped back to medtronic.Dried saline was found within the microcatheter hub.No damages or irregularities were found with the catheter hub, body, distal tip or marker bands.The catheter was flushed; and water exited out the distal end.An in-house 0.0160¿ mandrel was inserted into the catheter hub, through the catheter lumen and out the distal end with no resistance encountered.An in-house axium coil was then inserted into the catheter hub, through the catheter lumen and out the distal end with no resistance encountered.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance / stuck in catheter¿ and ¿catheter resistance¿ could not be confirmed.No resistance was encountered with the returned microcatheter and with an in-house mandrel or coil.The returned axium prime pusher could not be used for resistance testing as the implant coil was already detached and due to its damaged condition.As the implant coil and proximal segment of the pusher were not returned, any contribution of the implant coil and proximal segment towards the resistance could not be confirmed.Possible causes of resistance are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy or damage to pushwire.Customer reported continuous flush was not used and devices were prepared per ifu.The customer report of ¿pusher kink / broke¿ was confirmed.It is possible the break on the pusher occurred due to advancing / retracting the device against the reported resistance.The customer report of ¿difficult placement / positioning¿ could not be confirmed.This complaint cannot be confirmed through product analysis and customer did not submit any images / video for review.Possible causes of failure are patient vessel tortuosity, catheter tip under stress, catheter kick back or catheter compatibility.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10815842
• MDR Text Key: 215480632
• Report Number: 2029214-2020-01113
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536008106
• UDI-Public: 00847536008106
• Combination Product (y/n): N
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2020
• Device Model Number: APB-4-10-HX-SS
• Device Catalogue Number: APB-4-10-HX-SS
• Device Lot Number: A545554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other