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

Model Number APB-1.5-3-3D-ES

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the axium coil failed to detach.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the distal part of the basilar artery.The max diameter was 3mm, and the neck diameter was 2mm.The patient's vessel tortuosity was moderate.It was reported that detachment with the instant detacher was tried 3-4 times, but it was not successful.An attempt was made to detach the device manually. after the release wire was removed, detachment was tried, but it was still unavailable so the coil was captured with a snare and retrieved.Only a single instant detacher had been used during the procedure. the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).

Manufacturer Narrative

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

Event Description

Additional information was received indicating there were no issues encountered prior to the coil non-detachment.There were no effects on the patient and there were no discomfort or problems associated with the push wire itself.

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.

Manufacturer Narrative

H3: as found condition (condition of returned device): an axium prime coil, an instant detacher, an unknown catheter, and a 4 fr non-medtronic snare were returned within a shipping box and within a resealable plastic bag.Visual inspection/damage location details: (pli-10) the axium prime coil was returned within the separated distal segment of an unknown catheter.The actuator interface was found intact and attached to the coupler tube.There did not appear to be evidence of mechanical detachment using an instant detacher at this location.The axium prime pushwire was found to be kinked at ~18.2cm from proximal end.The coin was found still against the lumen stop with what appeared to be blood underneath the outer jacket.The shield coil was found intact with the implant coil already detached but returned.The implant coil was found stretched and damaged with the polypropylene filament intact.(pli-20) visual inspection of the assembled instant detacher (id) showed no defects.During evaluation, the instant detacher was taken apart to evaluate the components.All components appeared to be normal.The surface around the bottom inner diameter of the instant detacher cap appeared to be clean.No other anomalies were observed.Testing/analysis (including sem reports): two in-house axium prime coils were then selected for testing with the instant detacher.No difficulty was experienced inserting the pushwire into the instant detacher, and the load indicators were not visible when the pushwire were fully seated in the instant detacher cap.The implant coils were successfully detached on the first attempt without any difficulty.The instant detacher cap inner diameter was measured to be 0.0143¿ with visual inspection system.The instant detacher was found to be within specifications (0.0140¿ + 0.0005¿/-0.0005¿).Conclusion: based on the analysis performed, the customer report of ¿non-detachment¿ could not be confirmed as the pusher was returned with the implant coil already detached.Based on the returned device, the pushwire was found kinked in the proximal section of the pusher, of either attempted device advancement against resistance, damage during use or during return shipping to medtronic for analysis.It is possible that the damage to the pusher contributed towards the non-detachment by restricting the movement of the release wire during detachment attempt.There was no indication that the event is related to a manufacturing issue, therefore a dhr review is not required.Based on the analysis findings, the customer report of ¿unable to detach¿ could not be confirmed.The event cause could not be determined.The returned instant detacher was used to successfully to detach in-house axium coils on the first attempt without any difficulty.There was no malfunction of the instant detacher or non-conformance to specification identified that led to the unable to detach issue.There is no indication that the event is related to a potential manufacturing issue, therefore a dhr is not required.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.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 BARE PL 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: 13002994
• MDR Text Key: 288388094
• Report Number: 2029214-2021-01605
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021150
• UDI-Public: 00847536021150
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: APB-1.5-3-3D-ES
• Device Catalogue Number: APB-1.5-3-3D-ES
• Device Lot Number: A985693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1