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

Catalog Number	MVP-9Q
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Physician attempted to use a microvascular plug 9q during patient treatment.The mvp plug was soaked in heparinized saline prior to use.The catheter was flushed before inserting the plug.Physician was closing a pulmonary systemic collateral from the innominate vein to the left superior pulmonary vein.The collateral was very tortuous.No resistance was felt when advancing the plug through the introducer sheath or the catheter.Physician advanced the plug and when he wanted to expand the plug, the expansion was suboptimal.The plug was re-sheathed into the catheter for repositioning but at that time the plug was damaged.It was decided to remove the plug.It was re-sheathed and at that moment it was cut, for this reason they had to remove everything and loose the position and do the puncture again.The doctor was able to remove the guide and plug.No strut fracture was observed.A replacement plug was used without any problems to complete the procedure.No medical or surgical intervention was needed to prevent a permanent impairment of a function.No patient symptoms or complications associated with this event and did not lead to or extend patient hospitalization.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the plug detached, but remained inside the microcatheter and they were able to remove it as a whole.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
Product analysis: the device returned with the mvp fully deployed and detached from the wire.Biologics were observed on the mvp.Part of the delivery wire still remained in the proximal marker.A kink/bend was observed on the delivery wire.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: 19608617
• Report Number: 2183870-2024-00197
• Device Sequence Number: 12392167
• Product Code: KRD
• UDI-Device Identifier: 00763000307813
• UDI-Public: 00763000307813
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K150108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2024

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: 03/31/2025
• Device Catalogue Number: MVP-9Q
• Device Lot Number: 230790153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 10/30/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/17/2024; 10/31/2024
• Date Device Manufactured: 03/20/2023
• 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
• Patient Age: 14 YR
• Patient Sex: Male