MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number NV-6-20-HELIX

Device Problems Therapy Delivered to Incorrect Body Area (1508); Stretched (1601); Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a concerto coil that had a detachment issue, was stretched with part of the detached coil extending into the parent artery.The patient was undergoing treatment in collateral off of left subclavian artery coil embolization.The location was in the middle of the artery.The patient¿s vessel tortuosity was moderate, and there was no calcification.There were no abnormalities in relation to the patient¿s anatomy.It was reported that the device was prepared per the instructions for use (ifu) with no issues identified.There was an unspecified issue with the detachment of the coil and the coil had resistance and was stretched and pulled so that half of the coil was within the coil pack at the intended location in the collateral off of the left subclavian artery.And the other half extended out, traversing the patient's descending aorta to the right common iliac artery.It was noted that patient vessel tortuosity was moderate.There were no other patient anatomy abnormalities.

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 indicated the patient was undergoing treatment of an aneurysm collateral off of the proximal left subclavian artery.It was clarified that the report of "resistance felt when the device broke" to mean there was difficulty with deployment of the coil.It was noted the coil may have been slightly oversized relative to the vessel, and appeared to kick the catheter out a minimal amount.The physician felt comfortable deploying with the instant detacher and noted the coil did not appear to detach correctly.The physician then attempted to withdraw the coil, and it appeared to be stuck in the catheter (merit swift ninja microcatheter).The manual detachment method was not used, and a couple detachment attempts were made with the instant detacher.The physician decided to complete treatment another day, and the coil pack was successfully removed on (b)(6) 2020 via endovascular approach.There was no harm to the patient and they were currently asymptomatic.

• Brand Name: CONCERTO NYLON
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11349011
• MDR Text Key: 232572019
• Report Number: 2029214-2021-00189
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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: 10/31/2023
• Device Model Number: NV-6-20-HELIX
• Device Catalogue Number: NV-6-20-HELIX
• Device Lot Number: B110655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 MO
• Patient Weight: 7