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

Model Number	APB-3-4-3D-ES
Medical Device Problem Codes	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil would not detach and was found damaged in the microcatheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the anterior communicating artery with a max diameter of 6 mm and a 4 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the spring coil es could not be detached normally during the communicating aneurysm operation, and the coil was retrieved and broken into the microcatheter.It was reported the coil was kinked/damaged.There was no friction or difficulty during testing or delivery.The continuous flush was administered during the procedure.The physician attempted to detach the coil with the instant detacher 5 times.The physician did try two more times with another instant detacher.  the reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id unk-nv-ap-id (lot: unknown); product type: ; implant date n/a; explant date n/a 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.
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 that there were no issues that resulted in the damage that was found.Prior to coil non-detachment, there were no issues encountered.
Additional Manufacturer Narrative
Product analysis: as found condition- the axium prime device was returned for analysis within a shipping box, within an unsealed plastic biohazard pouch and within an opened axium prime inner pouch.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: the axium prime pusher was not returned for analysis.The already detached implant coil was found damaged and stretched with the polypropylene filament unbroken.The detach element and detach element ball was found undamaged.Testing/analysis ¿ the detach element ball outer diameter was measured to be 0.0038¿, which is within specification (specification: 0.0038¿ ± 0.00010¿).Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the implant coil was returned already detached.There was no damages or irregularities found with the returned implant coil that would contribute towards the non-detachment.As the pusher and instant detacher used during the event were not returned for analysis, any contribution of the pusher and instant detacher towards the non-detachment could not be determined.The returned implant coil was c onfirmed to have ¿coil kink/damage¿.Possibly causes are patient vessel tortuosity or advancing against resistance.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: 18337117
• Report Number: 9612164-2023-06004
• Device Sequence Number: 8489351
• Product Code: KRD
• UDI-Device Identifier: 00763000313722
• UDI-Public: 00763000313722
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203432
• 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): 03/14/2024

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: 05/30/2026
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 226656027
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 02/23/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 01/16/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10...
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 58 KG