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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that an axium sheath was disconnected when the hoop was removed.The devices were prepared as indicated in the package insert.The patin was being treated for vad.Blood flow speed was normal and vessel tortuosity was moderate.No patient symptoms or complications were reported.Additional information received reported that there were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
(b)(4).Equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) ¿drawing(s) referenced: n/a ¿as found condition: the axium prime coil was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.¿visual inspection/damage location details: the axium prime coil was returned within its introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at positive load indicator.In addition, the axium prime psuhwire was appeared to be broken at break indicator and retained by released wire.The axium prime implant coil was found to be detached from pushwire and not returned for analysis.No damages or irregularities were found with the introducer sheath).No other anomalies were observed testing/analysis: n/a ¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿damage introducer sheath¿ could not be confirmed and the root cause could not be determined.No defect was found with returned axium prime introducer sheath that would have contributed to the event.Possible causes of failure is excessive tightening of rhv.In addition, users must use the axium coil in accordance with the axium coil ifu.All devices are 100% inspected for damage and irregularities during the manufacturing process.((b)(4) 2022-08-14) 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
The event is reported based on analysis results which indicated a possible reportable event.H3.Product analysis updated: 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; within a plastic bio-pouch; and within a dispenser coil.Visual inspection/damage location details: the axium prime coil was returned within its introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at positive load indicator.In addition, the axium prime psuhwire was appeared to be broken at break indicator and retained by released wire.The axium prime implant coil was found to be detached from pushwire and returned within introducer sheath.No damage was found with the axium prime implant coil within introducer sheath.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: n/a ¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿damage introducer sheath¿ could not be confirmed and the root cause could not be determined.No defect was found with returned axium prime introducer sheath that would have contributed to the event.Possible causes of failure is excessive tightening of rhv.In addition, users must use the axium coil in accordance with the axium coil ifu.All devices are 100% inspected for damage and irregularities during the manufacturing process.H6.Coding updated based on analysis results.E1.Facility updated with translated address information.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: 15327686
• Report Number: 2029214-2022-01471
• Device Sequence Number: 6314645
• Product Code: KRD
• UDI-Device Identifier: 00847536021020
• UDI-Public: 00847536021020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: 08/26/2024
• Device Model Number: APB-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 222827519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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 Sex: Unknown