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

Model Number	APB-3-8-3D-ES
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report regarding an axium coil break and stuck in the sheath.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 3 mm and a 5 mm neck diam eter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that on (b)(6) 2022, a 65-year-old female underwent surgery at the (b)(4) hospital of (b)(4).  dsa angiography confirmed a posterior communicating aneurysm of the right internal carotid artery, about 3-5mm.During the aneurysm embolization surgery, the surgeon used the detachable spring coil apb-3-8-3d-es.When the coil was pushed, it broke, and after sufficient saline perfusion, it still could not be pushed out from the protective sheath, and could not be pushed into the lesion, making it unusable.The same model of spring coil was replaced with during the surgery, and it successfully reached the lesion location and the surgery was completed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
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.
Event or Problem Description
Additional information received clarified that fracture was observed to the coil.The coil had been attempted to be detached with the instant detacher twice.The coil was implanted.The introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
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.
Additional Manufacturer Narrative
Product analysis #(b)(4): as found condition: the axium prime implant coil was returned for analysis within a shipping box; and within an opened axium prime outer carton and inner pouch.There was no pushiwre, microcatheter returned with the device.Therefore, any contributing factors could not be assessed.Damage location details: only the partial axium prime implant coil was returned for analysis.The axium prime implant coil was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The axium prime implant coil was found to be damaged and stretched.No other anomalies were observed.Testing/analysis: the implant coil tip od (outer diameter) was measured to be within specifications.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil separation/break¿ was confirmed as the axium prime coil was returned detached from pushwire.However, the root cause could not be determined.Possible causes for coil separation/break are: tortious anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation and user advances the coil against resistance.Since the pushwire was not returned for analysis, any contributing factors could not be determined.It was noted the vessel tortuosity was normal.However, based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the introducer sheath was not returned.The axium prime implant coil was found to be damaged and stretched.It is possible the axium prime implant coil became damaged during preparation; however, the root cause could not be determined.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: 15999655
• Report Number: 9612164-2022-04780
• Device Sequence Number: 14854661
• Product Code: KRD
• UDI-Device Identifier: 00847536021242
• UDI-Public: 00847536021242
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2023

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: 12/12/2024
• Device Model Number: APB-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: 223479734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 12/26/2022; 02/18/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/06/2023; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female