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

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a 1.5-2-hx axium coil was not inserted at the microcatheter hub.So, as a result it was removed and the coil was checked, it turned out to be a coil pre-detached.The procedure was completed by replacing it with an same size axium coil.It was reported there was coil resistance/stuck in catheter hub.It is unknown if the coil was pushed smoothly out of the introducer sheath.There was no catheter damage or coil damage observed.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
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): as found condition: the axium prime coil was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location detail: the actuator interface was found securely attached to the coupler tube.The break indicator was found intact.No evidence of detachment attempts was found at these locations.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found damaged and stretched with the polypropylene filament broken.Testing/analysis: the implant coil could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ was confirmed as the damages found is consistent with resistance.The cause of the resistance could not be determined.Possible causes for coil resistance at catheter hub are, but not limited to, incompatible micro catheter, micro catheter damage, failure to hydrate the coil prior to use, failure to utilize continuous flush, and use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).The returned axium prime implant coil was found damaged/stretched and the pusher was found kinked/bent.Customer reported no coil damages were found and did not report any issues during hydration.Therefore, it is possible the damages occurred during the attempt to push the coil into the micro catheter hub against the reported resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The customer report of ¿premature detachment¿ could not be confirmed as the returned axium prime implant coil was unbroken.However, the implant coil was found severely stretched, and it is likely the stretching was misidentified as a detachment.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-81805), ruler (m-83360), 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 and within a sealed plastic biohazard pouch.The unknown micro catheter used in the event was not returned for analysis.Visual inspection/damage location detail: the actuator interface was found securely attached to the coupler tube.The break indicator was found intact.No evidence of detachment attempts was found at these locations.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found damaged and stretched with the polypropylene filament broken.Testing/analysis: the implant coil could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ was confirmed as the damages found is consistent with resistance.The cause of the resistance could not be determined.Possible causes for coil resistance at catheter hub are, but not limited to, incompatible micro catheter, micro catheter damage, failure to hydrate the coil prior to use, failure to utilize continuous flush, and use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).The returned axium prime implant coil was found damaged/stretched and the pusher was found kinked/bent.Customer reported no coil damages were found and did not report any issues during hydration.Therefore, it is possible the damages occurred during the attempt to push the coil into the micro catheter hub against the reported resistance.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.The customer report of ¿premature detachment¿ could not be confirmed as the returned axium prime implant coil was unbroken.However, the implant coil was found severely stretched, and it is likely the stretching was misidentified as a detachment.Ngod10 2023-04-08 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 that two or three attempts were made using manual/instant detacher.There was no kink/damage observed on the pushwire.

• 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: 16551972
• Report Number: 2029214-2023-00483
• Device Sequence Number: 4937536
• Product Code: KRD
• UDI-Device Identifier: 00847536032125
• UDI-Public: 00847536032125
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2023

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: 08/12/2024
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: B249794
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 04/09/2023; 06/21/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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