MAUDE Adverse Event Report: COVIDIEN LP EVERFLEX WITH ENTRUST DELIVERY SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Lot Number B184024

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2022

Event Type  malfunction  

Event Description

During vascular case, the surgeon tried to deploy stent.It partially got deployed, then it did not come out fully as they tried to unsheathe it, it twisted on the wire and got stuck; however, it was removed successfully.

• Brand Name: EVERFLEX WITH ENTRUST DELIVERY SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 14287812
• MDR Text Key: 290782978
• Report Number: 14287812
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2022

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 Lot Number: B184024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 83 KG