MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVX35-08-060-150

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

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

Event Date 03/18/2024

Event Type  malfunction  

Event Description

A physician used an everflex entrust stent to treat a moderately calcified plaque lesion in the common iliac artery of a patient.No damage to the package, such as the outer box, hoop, or tray, observed.No issues noted when removing the device from the hoop/tray.The device was prepped per the ifu.It is reported there was damage or dislodgement of the locking pin, tubing components during device preparation, external to patient.After pre-expansion, when it was tried to remove the locking pin to deliver and deploy the everflex, the accompanying tube assembly was torn apart at the base and remained within the handle.The wheel was turned but did not rotate.After disassembling the handle, the everflex was deployed manually and successfully placed at the lesion site.The procedure was completed after confirming that it was successfully placed at the lesion site.The device did not pass through a previously placed stent.No resistance when delivering the device.No excessive force used.No symptoms or complications.No patient injury.

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.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 19124686
• MDR Text Key: 340380025
• Report Number: 2183870-2024-00127
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVX35-08-060-150
• Device Lot Number: B507718
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 01/24/2023
• 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