MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	FC-4-8-3D
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	05/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that axium coil premature detachment occurred.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left internal carotid artery ophthalmic a rtery segment with a max diameter of 4.1 mm and a 3.5 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.The patient's past medical history includes no basic disease, but a small intracranial aneurysm found in physical examination.It was reported that the coil was detached in the microcatheter, withdrawn as a whole, and then re-placed the microcatheter to the d esignated aneurysm position.The microcatheter was not damaged.When the coil was delivered to the carotid bifurcation, the coil detached naturally, and finally the whole system was withdrawn, and a new coil was re-implanted.It was reported coil separation/break/ premature detachment occurred.The coil was removed from the patient by withdrawing with the microcatheter.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a cook 6f sheath, echelon 10 microcatheter, and stryker scyhlon guidewire.
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.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 that the catheter model and lot number are unknown.The coil did not fracture into multiple pieces.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within an opened axium prime inner pouch.The echelon-10 micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The coin was found still against the lumen stop.The coin was found undamaged.The shield coil was found stretched.The implant coil was already detached and not returned for analysis.Customer reported the implant coil detached within the micro catheter.The retainer ring was found undamaged.Testing/analysis: the inner diameter of the retainer ring was measured to be 0.0046¿, which was within specification (specification: 0.00455¿ ± 0.00010¿).The release wire was extending out of the pusher ~0.0037¿ which is within specification (specification: 0.002¿ - 0.005¿).The coin was measured to be ~0.078mm @ 0.063mm, ~0.089mm @ 0.0127mm, and ~0.091mm @ 0.0275mm; which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.0105mm @ 0.0127mm; and 0.086mm ¿ 0.0108 @ 0.0275mm) no other anomalies were observed.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" was confirmed; however, the cause could not be determined.Possible causes are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pusher rotation, user advances the coil against resistance, and detachment ball outer diameter below specification/damaged.Customer reported vessel tortuosity as minimal, no resistance was encountered, no repositioning occurred, no rotation of the pusher, continuous flush was administered, and the devices were prepared per ifu.There were no irregularities or non-conformance to specifications found that would contribute towards the premature detachment.As the echelon-10 micro catheter and implant coil (including the detach element) were not returned for analysis, any contribution of the micro catheter, implant coil and detach element to t he premature detachment could not be determined.The shield coil was found stretched.Possible causes for shield coil stretch 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, pusher rotation and user advances coil against resistance.Therefore, the root cause could not be determined.The shield coil was found stretched, potentially from retracting against resistance.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 FRAMING COIL
• 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: 16946152
• Report Number: 9612164-2023-02082
• Device Sequence Number: 6376223
• Product Code: KRD
• UDI-Device Identifier: 00847536038684
• UDI-Public: 00847536038684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K162704
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

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: 10/01/2024
• Device Model Number: FC-4-8-3D
• Device Catalogue Number: FC-4-8-3D
• Device Lot Number: 223026536
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 07/09/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 05/22/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Unknown