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

Model Number APB-3-8-HX-ES

Device Problems Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Stroke/CVA (1770); Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2022

Event Type  Death  

Event Description

Medtronic received a report that when first using the apb-5-15-3d-ss and apb-3-10-hx-es there was success with both products.The proximal lobe was framed with apb-4-8-3d-ss and had no issues, the basket was filled with apb-3-8-hx-es and this is when a complication was encountered.The apb-3-8-hx-es was filling the sac well until about 2cm was left to go in when suddenly it started to protrude into the parent artery so it was pulled back and tried to reposition the microcatheter in the aneurysm.Then they proceeded to advance the coil again and protrusion occurred again.An attempt was made to push in the remainder of the coil when all of sudden the doctor said that the remainder of the coil inside the microcatheter was not moving.They removed the microcatheter out of the aneurysm sac and it was discovered that the coil had detached thus remainder of the coil remained in a2.They tried to snare the coil out for several hours with no luck, they then tried giving the avigo a shape and entangling it with the outside piece of the coil to try and snare it out that way but it too was unsuccessful.While attempting to hook the coil, the avigo wire broke in a2 leading to the ica so now there were two foreign bodies in the vessels, protruding strand of coil and a piece of the avigo wire.The case was abandoned after the second complication and kept the patient on anti-coagulants.On (b)(6) 2022, the doctor attempted again to remove the avigo from the patient but the patient was not doing well as they had dilated pupil, thus the case was abandoned.The patient died on (b)(6) 2022.A continuous flush was administered during the procedure.The devices used during the procedure were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a bilobed shape, unruptured aneurysm in the pericallosal with a max diameter of 6mm and a 3.5mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include: medtronic 5fr navien, lot no: b244476, medtronic phenom 17, lot no: se20-041, and medtronic avigo, lot no: b368591.

Manufacturer Narrative

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

Event Description

According to the doctor it was because of stroke, and the coil was hanging in the parent artery (a2) which is what caused the stroke.

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: 15024607
• MDR Text Key: 295947600
• Report Number: 2029214-2022-01162
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000313975
• UDI-Public: 00763000313975
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-3-8-HX-ES
• Device Catalogue Number: APB-3-8-HX-ES
• Device Lot Number: 223729446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female