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

Model Number APB-2-6-HX-ES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2023

Event Type  Injury  

Event Description

Medtronic received a report that the axium prime coil prematurely detached.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the right middle cerebral artery (mca) bifurcation.The max diameter was 5.33mm, and the neck diameter was 3.16mm.The patient's blood flow was normal, and their vessel tortuosity was moderate.It was reported that there was no resistance felt while pushing out from the coil introducer.While a few centimeters of the coil were already pushed inside the aneurysm, the distal end of the pusher wire suddenly snapped and detached from the coil.The coil failed to be retrieved using a trevo stent and remained in the vessel.It was not implanted in the intended location, and the patient required dual antiplatelet treatment for 6 months.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not reposition the coil, attempts to detach the coil, or rotate the delivery pusher.A continuous flush had been administered. the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a boston scientific soft tip 40xf guide catheter, excelsior sl-10 microcatheter, and transend.014 guidewire.

Manufacturer Narrative

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16321521
• MDR Text Key: 309019175
• Report Number: 2029214-2023-00206
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536032194
• UDI-Public: 00847536032194
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: B128475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 65 KG