MAUDE Adverse Event Report: CORDIS CORPORATION CORDIS SMART CONTROL; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number C10080MB

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Patient with necrotizing pancreatitis, esrd(end stage renal disease), presenting with svc(superior vena cava) syndrome.Plan to sent the svc and the left brachiocephalic vein.The smart stent was being deployed in the svc(superior vena cava) in the standard way per ifu(instruction for use), but the stent shot forward into the right atrium.When we took out the delivery device, we found a clear plastic tubing on the wire that had broken off the device.The stent was retrieved and deployed in the left common external iliac vein.

• Brand Name: CORDIS SMART CONTROL
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION
• MDR Report Key: 16573783
• MDR Text Key: 311682314
• Report Number: MW5115828
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: C10080MB
• Device Catalogue Number: C10080MB
• Device Lot Number: 18035325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic