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

Model Number	APB-3-6-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that failed to detach.The patient was undergoing a coil embolization procedure to treat an unruptured wide-necked saccular anterior and posterior communicating artery aneurysm.The aneurysm max diameter was 3.8mm and the neck diameter was 3.5mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).One coil was delivered and detached normally.The second coil was apb-3-6-3d-es, lot: b162764.There was significant resistance while pushing the coil.Manual detachment was attempted multiple times but the coil could not be detached.It was noted that there was no attempt to detach with an instant detacher.Finally the coil was withdrawn and replaced to continue.The replacement coil was delivered smoothly and detached without issue.4 additional coils were delivered and implanted without issue to successfully complete the procedure.There was no harm or injury to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 that there was resistance with the axium coil in both the introducer sheath and the catheter.There was resistance pushing the coil out of the sheath but it was able to be pushed out.Resistance was then also felt in the echelon 10 microcatheter.
Additional Manufacturer Narrative
H3: the axium prime coil was returned for analysis.The axium prime pusher was found broken at ~167.5cm from the pusher distal end with the release wire extending for ~1.5cm.When compared to the product drawing, ~20.5cm of the pusher proximal end was found not returned.The implant coil was found within the introducer sheath.The implant coil appears to be in good condition within the introducer sheath.No damages were found with the introducer sheath.The implant coil was pushed out from within the introducer sheath without issue.No bends or kinks were found with the pusher.The implant coil was found still attached to the pusher.The implant coil was found in good condition.Upon microscopic inspection, what appears to be dried blood was found under the pusher shrink tubing at the lumen stop.The shrink tubing was removed, and dried blood was found at the lumen stop and on the release wire coin.The axium prime pusher was placed into the sonic cleaner to remove the dried blood.It was found that the release wire coin was found jammed into and broken at the lumen stop.Based on the device analysis and reported information, the customer¿s ¿coil resistance/stuck in catheter¿ and ¿coil resistance/stuck in sheath¿ reports could not be confirmed, and the cause could not be determined.No defect was found with the returned axium prime coil that would have contributed to the event.The echelon-10 micro catheter used in the event was not returned.Therefore, an analysis could not be performed and conformance to specification could not be assessed.Regarding the customer¿s ¿non-detachment¿ report the issue was confirmed.It is likely the jamming of the release wire coin at the lumen stop contributed to event.This can occur if the device is advanced against resistance.In addition, advancing the device against resistance can cause the presence of blood under the pusher shrink tubing contributing to the non-detachment issue.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: 12976259
• Report Number: 2029214-2021-01587
• Device Sequence Number: 4647230
• Product Code: KRD
• UDI-Device Identifier: 00847536031937
• UDI-Public: 00847536031937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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): 03/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: B162764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 02/11/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/06/2022; 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: 65 YR
• Patient Sex: Male