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

Catalog Number EVX35-06-150-120

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

Physician was attempting to use an everflex entrust self expanding stent to treat a lesion in the superficial femoral artery (sfa) in a patient.It was reported that during the procedure, at the moment to deploy the stent, when the physician started to rotate the deployment wheel, a wire came off from the locking pin.For this reason the physician decided to not use the device.The stent was partially deployed in the patient and then removed when full deployment was unachieved.No stent struts were exposed in patient.Device was safely removed from patient.The stent broke off in vitro while attempting to deploy after removal from the patient.No patient injury reported.

Manufacturer Narrative

Image review: the customer returned one image.The image shows an everflex entrust device with the inner lumen protruding though the red safety tab slot.Product analysis: the everflex entrust device was returned to medtronic investigation lab for evaluation.The device was returned coiled inside a biohazard pouch inside shelf carton.The device was returned with the red safety tab removed, the inner lumen exiting though the red tab slot and with a guidewire stuck in device.Guidewire confirmed as 0.035¿.The device was returned with approximately 8mm of the stent fully exposed and total length of stent returned confirmed as 137mm.This indicates that approximately 13mm of the stent broke off.The handle was cracked open, the inner lumen was kinked, and it was found that the pull wire was still attached to the outer shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12874561
• MDR Text Key: 288609994
• Report Number: 2183870-2021-00430
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: B222168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Date Device Manufactured: 06/17/2021
• 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