MAUDE Adverse Event Report: COVIDIEN EVERFLEX; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number EVD35-06-100-120

Device Problems Difficult or Delayed Activation (2577); Malposition of Device (2616); Mechanical Jam (2983)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

Patient brought to operating room for angiogram of left leg with interventions.When surgeon attempted to deploy the stent everflex stent 6 x 100 x 120 (evd3-06-100-120) lot# b520208, it would not deploy.Surgeon then attempted to remove the stent, and stent began to deploy on its own.Surgeon had to place stent in that position.

• Brand Name: EVERFLEX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16742337
• MDR Text Key: 313306777
• Report Number: 16742337
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2023

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
• Device Operator: Health Professional
• Device Model Number: EVD35-06-100-120
• Device Lot Number: B520208
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: Black Or African American