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

Catalog Number MVP-7Q

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

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.

Event Description

Physician attempted to use an mvp-7q device during treatment of a 10mm lesion the patient¿s left mid pulmonary artery.Moderate vessel tortuosity and minimal vessel calcification were reported.Lesion exhibited no stenosis.Artery diameter reported as 5.5mm.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 mvp plug was soaked in heparinized saline prior to use.The catheter was flushed before inserting the plug.A continuous flush was not maintained during the procedure as the patient was an infant.The device was not passed through a previously deployed stent.The inner diameter size of catheter used for delivery was 6f.It was reported the mvp detached in the delivery catheter.Removal difficulties were also reported. no vessel damage reported.The device was safely removed from patient.A replacement mvp-7q was used to complete procedure.No patient injury reported.

• Brand Name: MICROVASCULAR PLUG
• Type of Device: 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: 18985594
• MDR Text Key: 339238724
• Report Number: 2183870-2024-00105
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000702106
• UDI-Public: 00763000702106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MVP-7Q
• Device Lot Number: 232720017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Date Device Manufactured: 09/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 DA
• Patient Sex: Male
• Patient Weight: 3 KG