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

Model Number QC-4-10-3D

Device Problems Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding an axium coil that had issues with non-detachment and then was stretched and implanted at an unintended location.The patient was undergoing a coil embolization procedure to treat an unruptured saccular right pericalosa aneurysm.The aneurysm measured 11.5 x 5.5mm with a neck diameter of approximately 4mm with a frontopolaris branch.The patient's blood flow and vessel tortuosity were noted to be normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The complaint coil was the sixth and final coil to be implanted in the procedure.After successful placement/positioning of the coil, a detachment attempt was made with the instant detacher (id).The detacher broke the pushwire as expected but the coil did not detach.The id was then tried 4 times without successful detachment.Another id was not tried.It was noted that there was no issue with the id.One attempt was then made at manual detachment and the pushwire separated where the id had broken the pushwire.The detachment wire was seen normally inside but despite pulling it, the coil was still attached to the pushwire.It was noted that during the emergency manual detachment there was very intensive microcatheter flushing.Later there was an attempt to remove the entire coil into the microcatheter but during the removal process, the coil stretched and it was not possible to retract the entire coil into the microcatheter and attempts to remove the coil were showing dangerous pulling at the aneurysm sac.To avoid perforation or rupture, it was decided to leave the stretched coil proximally up to the level of the descending aorta.The patient had no associated symptoms.It was noted that there was no friction or difficulty during testing or delivery of the coil.The physician did not reposition the coil.

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 Description

Additional information received reported it was unclear how the coil eventually detached but it detached from the pushwire at the level of the aortic arch after the partial removal of the microcatheter from the aneurysm and ica/cca.No additional device was used and no additional action was taken to secure the coil.It was confirmed that there was not considered to be a problem with the id because it successfully detached 5 previous axium coils and the complaint coil was impossible to detach even with the emergency manual technique.

Manufacturer Narrative

H3: product analysis #279895757:equipment used- video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) drawing(s) referenced: n/a as found condition- the axium device and unknown micro catheter were returned for analysis within a shipping box and within two resealable tyvek pouches.The axium device was returned further within a piece of surgical wipe.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: the axium pusher was found broken at the positive load indicator.The proximal segment was not returned, therefore, any evidence of detachment attempts using an instant detacher could not be determined.The axium pusher was found broken at the break indicator.This is indicative of a manual detachment at this location.The pusher was found bent at ~68.5cm from the proximal end.The coin was found broken near the distal end.The distal coin was found still within 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.Blood was found within the lumen stop.No damages or irregularities were found with the micro catheter hub.The micro catheter was found kinked at ~1.8cm from the distal end.No damages or irregularities were found with the distal tip and marker band.Testing/analysis ¿ the micro catheter inner diameter was measured to be 0.0165¿ which is compatible for use with the axium coil.Conclusion - based on the customer report and device analysis, the customer report of "premature detach.From a non-detach" was confirmed.The likely cause of the non-detachment is the coin became stuck within the lumen stop.It is likely the coin became stuck due to the dried blood.The detachment is due to the break in the implant coil from the detach element.Customer report of ¿coil stretch¿ could not be confirmed but is likely as the coil was found broken.It is likely the coil became stretched and broken due to being entangled with the previously set coils within the aneurism when the device was retracted.Other possible causes include, but not limited to, lack of hydration before procedure tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances/retracts the coil against resistance or incompatible catheter.The instant detacher and actuator interface used in the event was not returned.Therefore, any contribution of this subassembly and the instant detacher towards the premature detach from non-detachment and conformance to specification could not be assessed.Ngod10 2022-09-05 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 3D
• Type of Device: 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: 14977800
• MDR Text Key: 295623530
• Report Number: 2029214-2022-01139
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536037779
• UDI-Public: 00847536037779
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2022

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
• Device Operator: Health Professional
• Device Model Number: QC-4-10-3D
• Device Catalogue Number: QC-4-10-3D
• Device Lot Number: 223179353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 09/06/2022
• Supplement Dates FDA Received: 07/12/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 75 KG