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

Model Number	APB-1.5-4-HX-ES
Medical Device Problem Codes	Break (1069); Stretched (1601); 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	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after the microcatheter was in place, the surgeon started to perform the spring coil filling.After 2 coils were successfully filled, the apb-1.5-4 coil was continued to be filled.After the surgeon hydrated it normally in vitro, it entered the microcatheter.When the microcatheter was pushed halfway, it was found that the resistance increased significantly.The spring coil was withdrawn from the body to be checked, it was found that the tip end was stretched.Coil separation/break and premature detachment occurred.The coil was removed from the patient.The coil was detached in the microcatheter and not implanted.The surgeon thought it was a product quality problem and asked to return it, please identify it.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was friction/difficulty during delivery.The physician did not reposition the coil and did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.The reported devices and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured right side posterior communicating small aneurysm with a max diameter of 3.2 mm and a 2.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.Ancillary devices include a 8f short sheath, 8fguidding guide catheter, and an echelon 10 microcatheter.
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
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 the resistance was in the proximal section of the catheter.The coil came out of the introducer sheath smoothly.There were no issues that resulted in the damage that was found.There were no detachment attempts made.
Additional Manufacturer Narrative
H3: analysis of the axium coil (lot# 223624044) found no damages or irregularities were found with the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The break indicator was found intact.This is indicative that a manual detachment was not performed.The axium coil pushwire was found to be kinked at ~69.1cm from proximal end.The shield coil was found intact with the implant coil still attached.The implant coil was found stretched and damaged with the polypropylene filament intact.No other anomalies were observed.Based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwire was returned with the implant coil still attached.Possible causes for ¿coil separation/break¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.There is no indication that the event is related to a potential manufacturing issue.Based on the analysis performed, the customers report of ¿coil stretch¿ was confirmed.Possible causes for ¿coil stretch¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.Based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the axium implant coil was still attached.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: 15663193
• Report Number: 2029214-2022-01785
• Device Sequence Number: 12257080
• Product Code: KRD
• UDI-Device Identifier: 00763000313845
• UDI-Public: 00763000313845
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2022

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: 01/14/2025
• Device Model Number: APB-1.5-4-HX-ES
• Device Catalogue Number: APB-1.5-4-HX-ES
• Device Lot Number: 223624044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 12/01/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/21/2022; 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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: 53 YR
• Patient Sex: Female