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 Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil detached during implantation and was found kinked/damaged.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right anterior cerebral artery with a max diameter of 4.6 mm and a 3.7 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the tip of the axium spring coil was detached during the implantation process and could not be implanted normally.It was reported the coil was kinked/damaged.There was no friction or difficulty during testing or delivery.The continuous flush was administered during the procedure.The damaged location is on the implant coil.The physician did not attempt to reposition the coil 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.
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
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 the casue of the premature detachment was not determined, detachment was found during delivery in the microcatheter.There were no issues that resulted in the damage that was found.No detachments attempts were made.The damage occurred before the delivery was completed.The coil was removed from the patient.The coil was not implantedat the intended location.The catheter was an echelon 10 catheter.Two coils were implnated before the event and 2 coils were implanted after.No surgical intervention was required.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a sealed tyvek biohazard pouch within a dispenser track.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.This is indicative mechanical method detachment was not attempted.The axium prime coil pushwire was found to be kinked at ~73.9cm from proximal end.The coin was found to be still against the lumen stop.The implant coil was found to be still attached.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the axium prime was returned with the implant still attached.The implant coil was found damaged, and the pusher was found bent/kinked.Possible causes for coil and pusher damage are patient vessel tortuosity, device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment.Based on the analysis performed, the customers report of ¿coil kink/damaged¿ was confirmed as the implant coil was found to be damaged.Possible causes are coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances or retracts the coil against resistance.There were no reported issues pushing the axium implant coil from within the introducer sheath during preparation per ifu.It is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv) subsequently causing the implant coil to become stuck.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18465326
• Report Number: 9612164-2024-00128
• Device Sequence Number: 7066413
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• 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): 04/04/2024

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: 05/31/2026
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 226487742
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: 01/11/2024; 03/14/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/05/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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: 64 YR
• Patient Sex: Female