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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
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 information that a axium coil detached unexpectedly and a solitaire stent couldn't be detached.The patient was being treated for an unruptured saccular aneurysm.Vessel tortuosity was minimal and patient blood flow was normal.It was indicated the devices were prepared as according to the instructions for use (ifu).  performed aneurysm embolization, chose apb-2-8-hx-es for filling, the coil was detached unexpectedly, chose sab-4-20 stent to hold down the broken coil, the stent couldn't be detached, and then replaced with another stent, smoothly completed the surgery.No patient symptoms were reported.
Additional Manufacturer Narrative
Follow-up report pertains to a previously submitted report with rr #: 2029214-2022-00072.B5.Updated with additional information received.Annex f coding corrected.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 no attempts had been made to detach the coil when the premature detachment occurred.Part of the coil was implanted in the intended position in the aneurysm and part remained outside the aneurysm but was successfully fixated with implantation of the solitaire ab stent.It was noted that a part of the coil was removed.
Additional Manufacturer Narrative
The axium pushwire was returned for evaluation inside of a biohazard bag and a shipping box.There was no coil returned with the pushwire.¿ visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil was intact and no damage.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire; it appeared that the manual detachment was attempted at this location.The ai and coupler tubing were present and intact; it appeared that the mechanical detachment was not attempted at this location.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.070mm @ 0.063mm; measured 0.085mm @ 0.127mm; measured 0.097mm @ 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 0.00273¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00462¿ and found to be within specification.¿ conclusion: based on the analysis performed, the customer complaint was confirmed as the pushwire was returned with the implant coil already detached from the pushwire.In addition, the pushwire was found bent and kinked at several locations.However, the root cause and cause for damage could not be determined.Based on the returned device, there was evidence of manual detachment as the pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.There was no non-conformance to specification identified that that led to the reported issue.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 implant not returned; any contribution of the implant coil to the reported 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.

• 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: 13307757
• Report Number: 2029214-2022-00072
• Device Sequence Number: 19689068
• Product Code: KRD
• UDI-Device Identifier: 00763000313906
• UDI-Public: 00763000313906
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2022

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: 07/10/2024
• Device Model Number: APB-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 222567177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/21/2022; 03/29/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/10/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2021
• 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 Sex: Unknown