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

Model Number EVD35-06-100-120

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

Patient with claudication underwent left leg angiogram via the femoral artery for everflex stent 6x100 insertion.The stent opened up halfway, got stuck and would not deploy all the way.The md was able to trouble-shoot the deployment device by opening it up while talking to the device rep on the phone.Manufacturer response for everflex stent 6x100, (brand not provided) (per site reporter).Device sent back to manufacturer today, 3/11/2020 therefore no response.

• Brand Name: EVERFLEX¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9888556
• MDR Text Key: 185225439
• Report Number: 9888556
• 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: 03/11/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 94