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

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).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
Medtronic received a report that the axium prime coil could not be detached and was stretched.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the left m1-m2 junction.The max diameter was 5.1mm, and the neck diameter was 3.9mm.The patient's blood flow was normal, and their vessel tortuosity was moderate.It was reported that the operator place the microcatheter well inside the aneurysm.The axium prime was the first coil used.They flushed the sleeve of coil as per the instructions for use (ifu) by putting coil sleeve half inside into the y connector and allowing saline flush through the coil sleeve.They then inserted the sleeve more inside towards microcatheter hub, tightened the rhv as per guideline, and placed the coil inside into the aneurysm, slowly pushing forward with 80% inflation of balloon.The operator could not detach the coil with the instant detacher or manual detachment.They made 5-6 attempts but it was not successful.While pulling the coil back inside into microcatheter the operator noticed the complete coil was inside but not getting further puled inside the microcatheter.They stopped pulling the coil and removed the entire microcatheter from the aneurysm.Replacement devices were used to finish the case.There had been no friction or difficulty during testing or delivery, and a continuous flush had been administered.The physician had repositioned the coil 2 times. the patient did not experience any injury or complications.The devices were prepared according to the ifu.Ancillary devices include a ballst sheath, neuron 6f guide catheter, sl10 microcatheter, and a traxcess 14 guidewire.
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 2 unsuccessful attempts were made to detach the coil using the instant detacher.5 or 6 unsuccessful attempts were made to detach the coil manually.There were no observed issues prior to the coil non-detachment.The pushwire was not damaged.It was considered possible that the patient's vessel tortuosity may have contributed to the issues.
Additional Manufacturer Narrative
H3.Product analysis: ¿ equipment used: video inspection system (m-85519) with microscope, ruler (m-83361), camera (panasonic lumix dmc-zs5); in-house instant detacher id-1-5 lot a149322 ¿ as found condition: the axium prime coil was returned for evaluation within the inner pouch and outer carton; inside of a biohazard bag and a shipping box.There was no instant detacher returned with the coil.¿ visual inspection/damage location details: the implant coil was still attached to the pushwire.The implant coil was found to be stretched.The coin located against the lumen stop.No bend was found on the pushwire.The break indicator was present and intact.The ai and coupler tubing were also found present and intact.There was no evidence of mechanical or manual detachment attempts to detach the coil.No other anomalies were observed.¿ testing/analysis: an in-house instant detacher was used to detach the coil.The implant coil was detached successfully on the 1st attempt.¿ conclusion: based on the analysis performed, the axium prime coil was confirmed to have "non-detachment" and "coil stretch" issues as the pushwire was returned with the implant coil was still attached but stretched.However, the root cause for the non-detachment and damage could not be determined.The implant coil detached successfully using an in-house instant detacher on 1st attempt.No issues were found during detachment of the coil.Since the instant detacher was not returned; any contribution of the instant detacher to the non-detachment issue could not be determined.H6.Coding update based on analysis results.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
• 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: 15210260
• Report Number: 2029214-2022-01343
• Device Sequence Number: 19996574
• Product Code: KRD
• UDI-Device Identifier: 00847536032019
• UDI-Public: 00847536032019
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2022
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A953001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/11/2022; 01/11/2023
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/22/2022; 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2019
• 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
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 69 KG