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

Model Number	APB-4-10-HX-SS
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: ¿ equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) ¿ as found condition: the axium prime coil was returned for analysis within a shipping box; and within a plastic bio-pouch.¿ visual inspection/damage: the axium prime coil was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The axium prime pushwire was found to be bent at ~2.2cm and ~9.0cm from proximal end.In addition, the axium prime pushwire was appeared to be appeared to be broken and separated at ~6.2cm from proximal end and with the release-wire extended out.The axium prime implant coil was found to be detached from pushwire and not returned for analysis.The shield coil was found to be broken.No other anomalies were observed.¿ testing/analysis: the coin was pulled back way from the lumen stop.The outer jacket was removed around the area of the lumen stop so the id of the lumen stop could be measured.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable with no sign of damage.The lumen stop inner diameter (id) and retainer ring inner diameter (id) were measured to be within specifications.The coin was measured in 3 locations and was found to be within specifications.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿pushwire separation¿ was confirmed.However, the root cause could not be determined.There were no non-conformances to specification identified that could have contributed to the event.The event is reported at this time based on analysis results which indicate a reportable event.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 pusher was kinked/broken.After the intraoperative cordis8f guide catheter was in place, and after choosing stryker synchro-14 guide wire with the echelon 10 microcatheter in place.The first coil was pushed through smoothly to the microcatheter until the aneurysm was detached normally.The second coil was smoothly pushed to the microcatheter until the aneurysm was detached normally.When the peime apb-4-10-hx-ss was selected, it was smoothly pushed to the microcatheter until the aneurysm but when the proximal detachment point was detached and the push rod was directly broken.When detaching the second detachment point, the push rod was also directly broken.Finally, the wire was pulled out of the coil by a hemostatic forceps, which could be detached.The coil was replaced and the new coil was smoothly pushed to the microcatheter until the aneurysm was detached normally.The device was prepared as indicated in the ifu.A continuous flush was administered during the procedure.The damage location was at the pushwire proximal segment.The patient was being treated for an aneurysm in the anterior communicating artery.The aneurysm was ruptured.The aneurysm dimensions were 7mm max diameter and 4mm neck diameter.The vessel tortuosity was normal.
Additional Manufacturer Narrative
Product analysis #705030674: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: dwgs31195 rev.A , dwgs50523 rev.E and dwgs50520 rev.S as found condition: the axium prime coil was returned for analysis within a shipping box; and within a plastic bio-pouch.Visual inspection/damage: the axium prime coil was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The axium prime pushwire was found to be bent at ~2.2cm and ~9.0cm from proximal end.In addition, the axium prime pushwire was appeared to be appeared to be broken and separated at ~6.2cm from proximal end and with the release-wire extended out.The axium prime implant coil was found to be detached from pushwire and not returned for analysis.The shield coil was found to be broken.No other anomalies were observed.Testing/analysis: the coin was pulled back way from the lumen stop.The outer jacket was removed around the area of the lumen stop so the id of the lumen stop could be measured.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable with no sign of damage.The lumen stop inner diameter (id) and retainer ring inner diameter (id) were measured to be within specifications.The coin was measured in 3 locations and was found to be within specifications.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿pushwire separation¿ was confirmed.However, the root cause could not be determined.There were no non-conformances to specification identified that could have contributed to the even (nikkhs2 2022-07-29) 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 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: 15234721
• Report Number: 2029214-2022-01385
• Device Sequence Number: 17754001
• Product Code: KRD
• UDI-Device Identifier: 00847536038547
• UDI-Public: 00847536038547
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 08/04/2024
• Device Model Number: APB-4-10-HX-SS
• Device Catalogue Number: APB-4-10-HX-SS
• Device Lot Number: 222703990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 08/23/2022
• Date Device Manufactured: 08/04/2021
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG