MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-2-3D-ES
Medical Device Problem Codes	Break (1069); Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
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 stretched and had separated.The patient underwent aneurysm embolization used 2-2 coil.The spring coil stretched automatically when pushed.Gave a replacement.No patient harm was caused.No surgical or medical intervention was required.The coil was withdrawn from the patient.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not "reportion" the coil.The physician did attempt to detach the coil.One attempt was made with the instant detacher.One attempt was made with the manual method.One instant detahcer was used.The physician did not rotate the delivery pusher during the procedure.The devices were prepared as per the instructions for use (ifu).The patient was being treated for an unruptured, saccular aneurysm in the opthalmic artery.The max diameter was 4.71mm and the neck diameter was 3.3mm.The patient's blood flow was normal.Vessel tortuosity was moderate.No patient symptoms or complications were reported.  ancillary devices: cook sheath, johnson & johnson guide catheter, ev3 microcatheter, sy-2 guidewire.
Additional Manufacturer Narrative
H3: analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 was received that coil separation occurred and that coil stretch was the only issue.
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
New information was received.To clarify the if the coil separated/prematurely detached, the coil was stretched inside the microcatheter when being pushed.The issues that resulted in the damage that was found was the coil was stretched.Under das, there was resis tance during pushing.
Additional Manufacturer Narrative
Product analysis # (b)(4): as found condition: the axium prime coil was returned for analysis within a shipping box, within a plastic bio-pouch, and within an opened axium prime inner pouch (222255915).The axium prime coil was returned within its introducer sheath.Damage location details: the axium prime pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.No bends or kinks were found with the pusher.The axium prime implant coil was found stretched within its introducer sheath with the polypropylene filament broken.The implant coil was found still attached to the pusher.No breaks or separations were found with the implant coil.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿coil separation/break¿ and ¿premature detach.From non-detach¿ reports could not be confirmed.No breaks or separations were found with the device.In addition, the implant coil was found still attached to the pusher.There does not appear to be any attempts to detach the implant coil using either the instant detacher (id) or manual method (via hypotube).Regarding the customer¿s ¿coil stretch¿ report the issue was confirmed.Possible causes of ¿coil stretch¿ include user does not maintain a continuous flush, tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, user advances coil against resistance, or use of an incompatible catheter.Information regarding if a continuous flush was maintained was not reported; therefore, ¿user does not maintain a continuous flush¿ could not be ruled out as a potential cause.It was reported the physician did not reposition the coil and the vessel tortuosity was moderate; therefore, ¿coil is not retracted in a one-to-one motion with the implant pusher during repositioning¿ and ¿tortuous anatomy¿ were ruled out as a potential cause.The catheter used in the event was not returned.In addition, the make/model of the catheter was not reported.Therefore, ¿use of an incompatible catheter¿ could not be ruled out as a potential cause.It was reported there was r esistance during delivery (pushing).Therefore, it is likely that the implant coil became damaged during delivery subsequently stretching during removal.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 3D
• 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: 16007112
• Report Number: 2029214-2022-02146
• Device Sequence Number: 5793977
• Product Code: KRD
• UDI-Device Identifier: 00763000313678
• UDI-Public: 00763000313678
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/07/2023

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: 05/17/2024
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: 222255915
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 01/27/2023; 02/17/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/05/2023; 02/01/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 70 YR
• Patient Sex: Male