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

Model Number QC-7-30-HELIX

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

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding an axium coil that detached premature after non-detachment.The patient was undergoing a coil embolization procedure to treat an unruptured saccular right vertebral artery aneurysm.The aneurysm max diameter was 6.53mm and the neck diameter was 3.42mm.Blood flow was normal.Vessel tortuosity was minimal.It was reported that the axium coil and all accessory devices were prepared according to the instructions for use (ifu).When it was attempted to detach the coil and the detachment wire had been completely drawn out, detachment was not seen so it was decided to withdrawn the coil.When the pusher was pulled, the coil was accidentally detached.A solitaire was used to retrieve the coil from the patient's body.The coil was then replaced and the procedure was completed successfully with no injury to the patient.

Manufacturer Narrative

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

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 that the instant detacher was not used.Three detachment attempts were made with the hypotube/manual method.There was no kink/damage observed to the pushwire, and there were no issues prior to the non-detachment.

Manufacturer Narrative

H3: the axium pusher was returned for analysis.There was no instant detacher or catheter returned with the pusher.The implant coil appeared to be detached from the pusher and not returned.The coin along with the release wire found to be missing.The axium pushwire was found to be broken at break indicator.The proximal portion appeared to be separated from the pusher along the ai, coupler tubing, load indicator were found to be missing.Kinks and bends were found along the length of the pusher.No other anomalies were observed.The lumen stop and the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) and retainer ring inner diameter (id) were measured to be within specification.Based on the analysis performed, the customer report of ¿premature detach.From the non-de tach" was confirmed as the returned coil appeared to be detached from the pusher.However, the root cause could not be determined.The returned implant coil and pusher were found to be damaged.However, the cause for damages could not be determined.Since the ai, coupler tubing, load indicator were not returned; any contribution of the ai, coupler tubing, load indicator to the "premature detach from the non-detachment" issue could not be assessed.Bends were also found on the returned pushwire.This can also be indicative of either high tortuosity or damage during return shipping to medtronic for analysis.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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 HELIX
• 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: 14575093
• MDR Text Key: 301238694
• Report Number: 2029214-2022-00931
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536037458
• UDI-Public: 00847536037458
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/20/2022

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 Expiration Date: 04/26/2024
• Device Model Number: QC-7-30-HELIX
• Device Catalogue Number: QC-7-30-HELIX
• Device Lot Number: 222128306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 08/27/2022
• Supplement Dates FDA Received: 07/01/2022; 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 68 KG