MAUDE Adverse Event Report: MEDTRONIC MEXICO CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number NV-2-8-HELIX

Device Problems Therapy Delivered to Incorrect Body Area (1508); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2023

Event Type  Injury  

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.

Event Description

Medtronic received a report that two coils prematurely detached and remains in the patient.The coils were not implanted at the intended location.Another coil was used to push and secure the premature detached coils.There was no surgical or medicinal intervention required.The pushwire was bent or broken which was not done on purpose.The physician did reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.Continuous flush was administered during the procedure.It was unknown if the reported devices and any accessory devices were prepared as indicated in the ifu.It was unknown if any patient symptoms or further complications were reported as a result of this event.

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 was received that the cause of the premature detachment was unknown and noted that the coil detached suddenly and while repositioning.

• Brand Name: CONCERTO NYLON
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17469429
• MDR Text Key: 320489436
• Report Number: 9612164-2023-03555
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536044883
• UDI-Public: 00847536044883
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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 Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: 226145917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 09/07/2023
• Date Device Manufactured: 03/12/2023
• 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