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

Model Number	APB-2-3-HX-ES
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2022
Type of Reportable Event	Malfunction
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
Medtronic received a report that the axium prime coil broke.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right posterior communicating artery.The max diameter was 6.3mm, and the neck diameter was 3.1mm.The patient's blood flow and vessel tortuosity were normal.It was reported that after filling, the coil was detached and the detachment wire was pulled out of the push rod.There was no obvious resistance when the push rod was withdrawn.When it was withdrawn outside of the body, it was found that the detachment area of the spring coil was not detached and part of the coil body was still connected to the push rod by the detachment area.But the coil body was incomplete, the length was less than 3cm, and the broken end of the coil body had obvious wire drawing.The fluoroscopy and angiography showed no abnormal blood vessels and detachment of the intratumor coil body.Therefore, the surgery was completed and the patient had no adverse reactions.The coil was implanted in the intended location, and no medical/surgical intervention was required.The pushwire was not bent or broken, and there had been no friction/difficulty during delivery.The physician did not reposition the coil or rotate the pusher during the procedure.One manual detachment attempt had been made.A continuous flush had been administered. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include an8f guide catheter, echelon 10 microcatheter, and synchro 14 guidewire.
Additional Manufacturer Narrative
B5.Updated with additional information received.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 there were no known issue during the procedure to cause the damage to the axium coil.The cause of the issue was unknown.
Additional Manufacturer Narrative
H3: product analysis # (b)(4): equipment used- video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) as found condition- the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened axium prime inner pouch.Visual inspection/damage location details: the axium prime pusher was found broken at the break indicator; indicative of a detachment attempt at this location.The proximal segment (actuator interface, positive load indicator and part of the break indicator) was not returned for analysis.The release wire and coin were fully retracted out of the lumen stop/pusher and not returned for analysis.The axium prime pusher was found bent at ~22.8cm and ~107.3cm from the proximal end.The shield coil was found stretched.The implant coil was already detached and not returned for analysis.The customer reported the implant coil was implanted within the patient.Testing/analysis ¿ n/a conclusion - based on the customer report and device analysis, the reported ¿coil separation/break¿ was not confirmed.It is likely the stretched shield coil was mistaken for an implant coil break.Possible causes for shield coil damage are catheter resistance, patient tortuosity, lack of hydration before procedure, user does not maintain continuous flush, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or incompatible products.As the echelon-10 micro catheter used in the event were not returned for analysis, any contribution of the echelon-10 micro catheter towards the stretched shield coil could not be determined.The echelon-10 micro catheter is compatible for use with the axium prime coil.The pusher was found bent, potentially from advancing against resistance or damage during return shipping.The customer reported no damage to the pusher, no friction/difficulty during delivery, no repositioning of the coil, no rotation of the pusher, continuous flush was administered, patient vessel tortuosity as normal, and the devices were prepared per ifu.(ngod10 2022-10-26) 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 BRPL HLX
• 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: 15385884
• Report Number: 2029214-2022-01522
• Device Sequence Number: 14908157
• Product Code: KRD
• UDI-Device Identifier: 00847536020993
• UDI-Public: 00847536020993
• 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: 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2022

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: 06/07/2024
• Device Model Number: APB-2-3-HX-ES
• Device Catalogue Number: APB-2-3-HX-ES
• Device Lot Number: 222370250
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 09/13/2022; 10/27/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 09/29/2022; 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 55 KG