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

Model Number NV-7-30-HELIX

Device Problem Separation Failure (2547)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2023

Event Type  Injury  

Event Description

Medtronic received a report regarding two concerto coils that failed to detach.The patient was undergoing gastroduodenal artery (gda) treatment.It was reported that these are the 2 helix coils that we had issues with.Inevitably they were both deployed and implanted in the patient.As well as charged to the patient of course.The coils were placed in the gda with a non-tortuous approach.The rebar 18 was the microcatheter being used.At the close of the case it was noted that the internal release wire remained attached to the coil and partially within the aorta.The techs noted that the case seemed to go as normal until they had issues with the 2 - 7 x 30 helical coils.They did place a number of other coils without difficulty.It was reported that non-detachment occurred.It is not stated how many times the physician attempted to detach the coil with the instant detacher.The physician did try to detach with another instant detacher, but it is unknown how many times the second instant detacher was used.It is unknown if there was a manual attempt at detachment via hypotube.It was reported there was no issue with the instant detacher.  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.Ancillary devices include a rebar 18 microcatheter.

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.

• Brand Name: CONCERTO NYLON
• 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: 16223914
• MDR Text Key: 307896064
• Report Number: 2029214-2023-00099
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536033580
• UDI-Public: 00847536033580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2023

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: 02/17/2024
• Device Model Number: NV-7-30-HELIX
• Device Catalogue Number: NV-7-30-HELIX
• Device Lot Number: B162886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 01/23/2023
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other