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

Model Number	APB-4-6-3D-SS
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Healthcare professional information not available due to privacy laws.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
Medtronic received a report regarding phenom catheter resistance and axium coil premature detachment.The patient was undergoing intracranial aneurysm treatment of a saccular, unruptured aneurysm in the right side of the ophthalmic artery with a max diameter of 6 mm and a 5 mm neck diameter.The accessed vessel was the femoral artery with a diameter of 9 mm.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the aneurysm embolization surgery was performed and the shapeable microcatheter phenom plus was selected to establish the pathway.The microcatheter could not be pushed out.It was reported the catheter resistance occurred in the distal end.It was also reported the axium coil was selected and used to form a hoop.The spring coil was stretched.It is noted that coil separation/break/premature detachment occurred.The coil was removed from the patient.The coil was stretch and was immediately taken out.No surgical or medicinal intervention was required.The pushwire was not bent or broken.There was no friction or difficulty during delivery observed.The physician did not reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.
Event or Problem Description
Additional information was received that there were no issues that resulted in the stretched coil.It was clarified that during delivery, the coil stretched.No detachment attempts were made.
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):¿equipment used: video inspection system (m-78210), ruler 200cm (m-83361) ¿as found condition: the axium prime coil was returned for analysis within a shipping box; and within a sealed plastic bio-pouch.¿ damage location details: the axium prime implant coil was returned within its introducer sheath.However, the implant coil was deployed from introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.There is no evidence of any detachment attempts by mechanical or manual methods.However, the axium prime pushwire was found to be bent all over from ~24.0cm to ~2.0cm from distal end.The axium prime implant coil was still attached to the pushwire.The axium prime implant coil was found to be damaged and stretched.No separation/break were found.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.¿testing/analysis: the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.The axium prime implant coil was able to be pushed out from introducer sheath with resistance.¿conclusion: based on the device analysis and the reported information, the customer¿s report of ¿premature detachment¿ and ¿coil se paration/break¿ could not be confirmed as the axium prime implant coil was still attached to the pushwire and no separation/break were found.However, the axium prime coil was confirmed to be damaged and stretched.It is likely the damage occurred when attempting to remove the implant coil from the phenom plus catheter against resistance.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: 15936168
• Report Number: 2029214-2022-02076
• Device Sequence Number: 4951378
• Product Code: KRD
• UDI-Device Identifier: 00847536031982
• UDI-Public: 00847536031982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2023

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: 08/05/2023
• Device Model Number: APB-4-6-3D-SS
• Device Catalogue Number: APB-4-6-3D-SS
• Device Lot Number: B065380
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 02/14/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/21/2022; 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: Female