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

Model Number	APB-1.5-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coil could not be detached.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 4mm and a 2mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the coil could not be detached after the microcatheter was in place and the coil was filling.The operation was successfully completed by replacing with another coil. the device was prepared as indicated in the ifu.No patient symptoms or complications were reported.
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 one detachment attempt was made with the instant detacher, and one attempt was made with the manual method.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5), in-house instant detacher (model: id-1-5 lot: 9443624) as found condition- the axium prime coil was returned within a shipping box, within a sealed plastic biohazard pouch and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.There were no evidence of detachment attempts at this location with an instant detacher.The break indicator was found intact.No evidence of manual detachment attempts was found at this location.The axium prime pusher was found bent at ~34.5cm, ~40.5cm and ~104.0cm from the proximal end.The coin was found still against the lumen stop.The implant coil was found still attached to the pusher.The implant coil was found to be damaged within the introducer sheath.Testing/analysis ¿ an in-house instant detacher was then used for detachment testing.No difficulty was experienced inserting the pusher into the instant detacher, and the load indicator was not visible when the pusher was fully seated in the instant detacher cap, which is normal.The implant coil was successfully detached on the first attempt without any difficulty.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the device was returned with the implant coil still attached.However, the cause could not be determined.Customer reported one attempt with an instant detacher and one attempt was made manually, however, the actuator interface and break indicator were found unbroken.In addition, detachment testing, detached the implant coil with an in-house instant detacher with no issues found.The pusher was found bent; indicative of user advances/retracts the coil against resistance.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment could not be determined.There is no indication that the event is related to a potential manufacturing issue.H6.Coding updated based on analysis results.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
• 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: 12858623
• Report Number: 9612164-2021-04510
• Device Sequence Number: 17231237
• Product Code: KRD
• UDI-Device Identifier: 00847536021167
• UDI-Public: 00847536021167
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 02/01/2022

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: 06/08/2024
• Device Model Number: APB-1.5-4-3D-ES
• Device Catalogue Number: APB-1.5-4-3D-ES
• Device Lot Number: 222382268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 11/25/2021; 01/14/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/15/2021; 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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 Sex: Unknown