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	Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
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 information that an axium coil did not detach.During a coiling procedure, the coil could not be detached.The detachment attempts were made with an id-i-1 detacher.Manual detachment was not attempted as the doctor preferred to change the coil.No other anomalies were reported.The physician did not try another instant detacher.There was no issue with the instant detacher.The devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were reported.
Additional Manufacturer Narrative
H3: the axium prime coil was returned for evaluation.There was no instant detacher returned with the coil.The implant coil was still attached to the pushwire.No damage was found with the implant coil.The coin located against the lumen stop.No bend was found on the pushwire.The break indicator was present and intact.The ai and coupler tubing were also found present and intact.There was no evidence of mechanical or manual detachment attempts to detach the coil.No other anomalies were observed.An in-house instant detacher was used to detach the coil.The implant coil was detached successfully on the 1st attempt.Based on the analysis performed, the axium prime coil was confirmed to have "non-detachment" issue as the pushwire was returned with the implant coil was still attached.However, the root cause could not be determined as the implant coil was detached successfully using an in-house instant detacher on 1st attempt.No damages were found with the returned coil and pushwire.No issues were found during detachment of the coil.There was no non-conformance to specifications identified that led to the reported issue.Since the instant detacher was not returned; any contribution of the instant detacher to the non-detachment issue 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.
Event or Problem Description
Additional information received reported that no anomalies were noted neither during the insertion nor delivery of the coil.It was observed that there was damage to the pushwire near to the manual marker detachment point.The patient was undergoing treatment for an apex left oblong aneurysm located in the a1 segment.The aneurysm size was 5mm x 2mm.The patient's vessel tortuosity was severe.

• 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: 15480225
• Report Number: 2029214-2022-01619
• Device Sequence Number: 5640050
• Product Code: KRD
• UDI-Device Identifier: 00847536038547
• UDI-Public: 00847536038547
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081465
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 03/02/2024
• Device Model Number: APB-4-10-HX-SS
• Device Catalogue Number: APB-4-10-HX-SS
• Device Lot Number: 221814281
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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: 68 YR
• Patient Sex: Male