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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
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 axium coil failed to detach, and it was unknown as to why.A replacement product from another manufacturer was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an aneurysm, and no additional lesion/vessel characteristics were made available.Ancillary devices include an sl-10 microcatheter, 6f envoy guide catheter.
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 from the physician indicated that more than 5 instant and manual detachment attempts were made.There were no issues prior to the non-detachment, and no damage was seen on the pushwire.
Additional Manufacturer Narrative
H3: analysis of the axium prime coil (model: apb-3-6-3d-es lot: a879024) found that the actuator interface was securely attached to the coupler tube, and the break indicator was intact.There was no evidence of detachment attempts using an instant detacher or by breaking the pusher at these locations.The coin was found present and still against the lumen stop with the shield coil present, but damaged.The implant coil was still attached to the pusher.The implant coil was found damaged and stretched with the polypropylene filament intact.An in-house instant detacher was used for detachment attempt.No difficulty was experienced inserting the pusher into the instant detacher, and the load indicator was not visible when the pusher was fully seated in the instant detacher cap, which is normal.The instant detacher failed to detach the implant coil.A detachment was then attempted by breaking the pusher at the break indicator and the release wire was pulled.The release wire did not retract and was stuck within the pusher.The distal outer jacket was removed, and dried blood was found within the jacket and lumen stop.The device was put into an ultrasonic cleaner to dissolve the dried blood.The release wire was retracted and found to still be stuck within the lumen stop.Attempts to remove the coin out of the lumen stop was unsuccessful and the distal pusher (lumen stop and retainer ring) broke from the rest of the pusher and due to its small size became lost.The lumen stop and retainer ring could therefore not be assessed.The coin was found to be damaged.No other damages or abnormalities were observed.Based on the analysis performed, the customer report of ¿non-detachment¿ was confirmed as the device was returned with the implant coil still attached.There was no evidence of detachment attempts using an instant detacher or by breaking the break indicator.The likely cause of the non-detachment is the coin was jammed within the lumen stop, and subsequently causing the implant coil to not detach.The coin was found damaged, indicative that it was either stuck within the lumen stop or damaged during extraction attempt during analysis.As the lumen stop was lost during analysis, conformation to specification and contribution towards the non-detachment could not be determined.The dried blood within the lumen stop and damage to the shield coil could have contributed towards the non-detachment.The implant coil was found damaged and stretched.Possible causes are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance or incompatible catheter.H6: method code updated to b01.Result code updated to c070601.Conclusion code updated to d15.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, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11167149
• Report Number: 2029214-2021-00050
• Device Sequence Number: 3501838
• Product Code: KRD
• UDI-Device Identifier: 00847536021235
• UDI-Public: 00847536021235
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2021

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: 06/03/2022
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: A879024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 01/13/2021; 03/19/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 01/25/2021; 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1