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

Model Number	APB-2-6-HX-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
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 regarding an axium coil that detached prematurely.The patient was undergoing a coil embolization procedure to treat an unruptured saccular cavernous sinus segment aneurysm.The aneurysm max diameter was 4mm and the neck diameter was 3mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).Continuous catheter flush was administered during the procedure.There was no friction or other difficulty during delivery of the coil.During the filling process, the coil detached premature and was implanted at an unintended location.It was noted that the physician had repositioned the coil 1 time but did not rotate the delivery pusher during the procedure and had not made any attempt to detach the coil.The pushwire was not bent or broken.A solitaire ab stent was then implanted to secure the coil.Post-operatively the patient was observed to have intracranial hemorrhage and a craniotomy procedure was performed to clear the hema toma.
Event or Problem Description
Additional information received reported that after the patient was involved in the surgery, a craniotomy was performed to clear the hematoma.The patient had been in the icu since then, had not recovered, and had died.
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.Product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the axium prime pusher was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and within an introducer sheath.The unknown micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: a purple string was found tied to the axim prime pusher.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.The pusher was found kinked at ~18.7cm from the distal end.The coin was found still against the lumen stop.The shield coil was found undamaged.The detach element was found still attached to the pusher.The implant coil was broken from the detach element and not returned for analysis.Under magnification the coil shell weld was found present conclusion: based on the analysis performed, the customer report of ¿premature detachment" was not confirmed; however, the implant coil was found separated/broken.Possible causes for implant coil break are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pusher rotation or user advance/retract the coil against resistance.The customer reported vessel tortuosity as normal, devices were prepared per ifu, continuous flush was used, and no friction/difficulty was observed during procedure.Therefore, the cause of the coil separation could not be determined.As the unknown micro catheter used in the event was not returned for analysis, any contribution of the micro catheter to the coil separation/break could not be determined.As the model and lot numbers of the catheter were not reported, compatibility could not be assessed.H6.Coding updated based on analysis results.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: 14802479
• Report Number: 2029214-2022-01056
• Device Sequence Number: 4879675
• Product Code: KRD
• UDI-Device Identifier: 00847536021013
• UDI-Public: 00847536021013
• 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): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 224121849
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 06/22/2022; 09/01/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/06/2022; 09/27/2022
• Date Device Manufactured: 04/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female