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

Model Number APB-2-3-3D-ES

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2022

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 coil could not be detached.After deployment of the stent, the embolization of the coil was satisfactory.After what they determined was detachment of the coil, it was found the coil had moved and not detached.After repeatedly adjusting the microcatheter and pushing the guide wire for two hours, the coil could not be detached.They decided to slow withdraw the system from the patient and the coil was detached when the coil was retracted into the microcatheter about 5mm and the coil was pushed into the tumor by using the push guide wire.There was still about 1mm left in the blood vessel and the stent was detached to press the coil to end the surgery.The devices were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 4mm and a 3mm neck diameter.It was noted the patient's blood flow was low and vessel tortuosity was moderate.

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 Description

Additional information was received indicating an instant detacher was not used.The manual method was used once, as the detachment wire was pulled out in half.There were no issues encountered prior to the coil non-detachment.

Manufacturer Narrative

H3.Product analysis: equipment used- video inspection system (m-81850), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition- the axium prime pusher was returned within a shipping box, within a sealed plastic biohazard pouch and within a dispenser coil.Visual inspection/damage location details: the axium prime pusher was found broken distal to the break indicator.The proximal segment (actuator interface, positive load indicator, coupler tube and break indicator) was not returned for analysis.The release wire was fully retracted out of the pusher and not returned for analysis.No other damages or irregularities were found with the pusher.The implant coil was already detached and not returned for analysis as it remained within the patient.Testing/analysis: under magnification, the outer jacket was removed.The lumen stop was found damaged (ovalized).The inner diameter of the lumen stop could not be reliably measured due to the damage.The retainer ring appears to be undamaged.The inner diameter of the retainer ring was measured to be 0.0045¿ which is within specification (specification: 0.00455¿ ± 0.00010¿).Conclusion - based on the customer report and device analysis, the customer report of " premature detach.From non-detach." was confirmed.The lumen stop was found damaged, indicative that the coin was jammed within the inner diameter of the lumen stop; causing the implant coil to not detach.It is likely the device then detached due to resistance once the device pusher was retracted out of the patient.The cause of the coin stuck within lumen stop could not be confirmed.As the release wire/coin, and implant coil were not returned, any contribution of the release wire/coin and implant coil towards the premature detachment from non-detachment could not be assessed.The customer report of ¿coil migration after deployment¿ is likely caused due to the non-detachment, causing part of the implant coil to be pulled out of the aneurism.H6.Coding updated based on analysis results.Additionally the device code (fdd/annex a) was corrected to reflect originally reported information that the coil detached prematurely during removal after failing to detach when attempted.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 3D
• 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: 13620977
• MDR Text Key: 289200591
• Report Number: 2029214-2022-00323
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000313685
• UDI-Public: 00763000313685
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: APB-2-3-3D-ES
• Device Catalogue Number: APB-2-3-3D-ES
• Device Lot Number: 221962245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 03/01/2022; 07/31/2022
• Supplement Dates FDA Received: 03/27/2022; 08/23/2022
• Date Device Manufactured: 03/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG