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)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/28/2022

Event Type  Injury  

Event Description

Medtronic received a report that after the detachment point reached the detachment zone, they manually detached the coil.They withdrew the push rod, and found that the coil was not detached.They repeatedly adjusted the position of the microcatheter, push rod and coil for half an hour but it still did not detach.They decided to withdraw the coil to vitro, on the way to withdraw, the coil detached.The coil went in the blood vessel and ran to the distal of the blood vessel with the blood flow.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left side a1 with a max diameter of 5*3mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.

Manufacturer Narrative

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

Event Description

Additional information received reported that the coil was not implanted in the intended location as it escaped to the distal blood vessel.No additional medical/surgical intervention was required.

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: the axium prime coil was returned for analysis.The axium prime pusher was found broken at the manual detachment location via hypotube break indicator (hbi).The release wire was not found extending out from within the broken end.The pusher was found bent at 32.0cm from the distal end of pusher.The pusher release wire coin was found not at the lumen stop, the shield coil was found stretched, and the implant coil was detached from the pusher.The detached implant coil was not returned as it remains within the patient.The release wire could not be located within the pusher; therefore, an analysis could not be performed.There was a appearance of dried residue within the pusher lumen stop.The pusher was placed in the sonic cleaner to remove the residue.After cleaning, the pusher¿s lumen stop and retainer ring inner diameters (id) were found in good condition.The lumen stop id could not be measured as residue was still within the id.The retainer ring id was measured to be 0.0046¿ which is within specification (specification: 0.00455" ± 0.00010).Based on the device analysis and reported information, the customer¿s ¿premature detachment from non-detachment¿ report was confirmed.In the event it is likely the bends at the distal end of the pusher contributed to the non-detachment issue.The pusher can become bent if advanced against resistance.In addition, as the coil shield was found stretched it is possible the coil shield became wrapped around the coil shell or proximal end of implant coil contributing to the events.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: 14274396
• MDR Text Key: 294653418
• Report Number: 2029214-2022-00751
• 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: 08/08/2022

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 Model Number: APB-2-3-3D-ES
• Device Catalogue Number: APB-2-3-3D-ES
• Device Lot Number: 222493628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/06/2022; 07/16/2022
• Supplement Dates FDA Received: 06/01/2022; 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG