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

Model Number	APB-6-20-3D-SS
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an axium coil that had resistance during delivery in the phenom catheter and was stretched and detached prematurely.The patient was undergoing a coil embolization procedure to treat an arteriovenous fistula (avf) with access via the external carotid artery (eca).Vessel tortuosity was severe.It was reported that the devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.When delivering the axium coil through the phenom catheter, severe tension was felt in the coil pushwire.An attempt was made to implant the coil but it could not be done so the physician decided to remove the coil.It was noted the physician did not reposition the coil.However, the coil then stretched suddenly and detached unintentionally.The stretched coil remained in the parent artery.The patient did not have any symptoms or complications related to the event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional 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.
Event or Problem Description
Additional information received reported the resistance in the catheter was in the distal section.The coil came out of the introducer sheath smoothly.There was no damage to the phenom catheter or pushwire was observed after removal.A detachment attempt was made before it detached prematurely.The coil was stretched and herniated from aneurysm and was not implanted.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: 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: 13978201
• Report Number: 2029214-2022-00550
• Device Sequence Number: 20222640
• Product Code: KRD
• UDI-Device Identifier: 00847536008281
• UDI-Public: 00847536008281
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: APB-6-20-3D-SS
• Device Catalogue Number: APB-6-20-3D-SS
• Device Lot Number: 222015340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/07/2022
• Date Device Manufactured: 04/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female