MAUDE Adverse Event Report: COVIDIEN MICROVASCULAR PLUG; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	MVP-9Q
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Chest Pain (1776); Thrombosis/Thrombus (4440)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician implanted a microvascular plug 9q in the patients left internal iliac vein ( (b)(6)2024).Moderate vessel tortuosity was reported.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.The device was passed through a previously deployed abre stent.The mvp plug was soaked in heparinized saline prior to use.The catheter was flushed before inserting the plug.A continuous flush was maintained during the procedure.Target vessel diameter reported as 7-9mm.The plug did fully open in the target vessel before detaching.Physician confirmed secure placement of mvp-9q under fluro.No contrast was seen which confirmed plug had opposed to vessel wall.On an unknown date post op, the patient was admitted to er at a hospital in another state after complaints of chest pain after physically bending over to pick up a child.Patient followed up with original physician who performed the procedure.A follow up computed tomography (ct) scan confirmed migration of plug from original target implantation area in left internal iliac vein to patients left pulmonary artery in lungs.Physician confirmed there is a clot around plug that migrated to pulmonary artery.No intervention has been carried out to date and there are no plans to remove it at this time.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Image evaluation: two images were provided for evaluation.Image0: this image shows a photograph taken of a screen that has a single image.There are no landmarks to identify what part of the body is shown.A medical device is noted in the picture, though no identifying factors to say what the medical device is.Image1: this image shows a photograph taken of a screen that shows a single image.There is contrast in vessels.This is not a video/run that would show where the contrast is flowing and where there is occlusion/embolized vessel.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MICROVASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19298543
• Report Number: 2183870-2024-00157
• Device Sequence Number: 6892352
• Product Code: KRD
• UDI-Device Identifier: 00763000702113
• UDI-Public: 00763000702113
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: MVP-9Q
• Device Lot Number: 232620086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 04/16/2024; 07/15/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 05/13/2024; 07/16/2024
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female