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

Model Number	APB-1-4-3D-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil experienced resistance in the middle of the echelon 10 microcatheter and the push wire was later found to be stretched and prematurely detached.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the anterior cerebral artery bifurcation.The max diameter was 5mm, and the neck diameter was 3.35mm.The patient¿s blood flow was normal, and the vessel tortuosity was minimal.It was reported that coil had great resistance after entering the echelon 10 microcatheter.After the spring coil was pushed out of one side of the catheter, when adjusting the position of the spring coil, it was found that the spring coil could not be withdrawn into the microcatheter.The expert chose to withdraw the microcatheter and the coil as a whole.After the withdrawal, the coil was pushed out and found that the coil was separated from the push wire and the distal push wire was stretched.A continuous flush was administered.The physician had repositioned the device once.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).
Event or Problem Description
Additional information received reported that the coil did not come out of the introducer sheath smoothly.
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
H3: the pushwire was returned for evaluation inside of a biohazard bag and a shipping box.There was no implant coil or echelon 10 catheter returned with the pushwire.Visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil was found to be stretched.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at distal break indicator (manual detachment location); retained by the release wire.The ai and coupler tubing were found present and intact.The pushwire was found to be bent at 19.0cm to 36.0cm from the distal retainer ring.Testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.071mm @ 0.063mm; measured 0.083mm @ 0.127mm; measured 0.095mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00282 and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00462¿ and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.In addition, the echelon 10 catheter appeared to be compatible for use with the coil as it has a labeled inner diameter (id) of 0.017".The returned coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the analysis performed, the customer complaint was confirmed.However, the root causes could not be determined.The pushwire was returned with the implant coil already detached.The pushwire was bent at several location.Additionally, the pushwire was found broken at manual detachment location with the coin pulled back from the lumen stop.The pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.It is likely that these damages occurred when the customer attempted to advance the coil through the catheter against the reported resistance.Possible causes include the use of damaged catheter, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.There was no non-conformance to specification identified that led to the reported issues.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the catheter was not returned; any contribution of the catheter to the reported issues 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.

• 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: 13078227
• Report Number: 2029214-2021-01667
• Device Sequence Number: 19897535
• Product Code: KRD
• UDI-Device Identifier: 00847536031838
• UDI-Public: 00847536031838
• 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
• Report Date (Section B): 02/28/2022

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: 11/16/2023
• Device Model Number: APB-1-4-3D-ES
• Device Catalogue Number: APB-1-4-3D-ES
• Device Lot Number: B119021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 12/25/2021; 02/10/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/19/2022; 02/28/2022
• Date Device Manufactured: 11/16/2020
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 80 KG