MAUDE Adverse Event Report: CORDIS CORPORATION S.M.A.R.T.; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	C14080SB
Health Effect - Clinical Codes	Chest Pain (1776); Cardiac Tamponade (2226); Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A transhepatic biliary self-expandable smart control stent (7fr 14mm x 80mm) was inserted into the patient's left iliac vein in our interventional radiology suite.Three hours later the patient returned to our ir suite with chest pain.Under fluoroscopy it was discovered that the stent had migrated to the inferior vena cava-right atrial junction.Life-saving interventions were required to remove the stent.The patient had complications of cardiac effusion/tamponed, which required life saving surgery.

• Brand Name: S.M.A.R.T.
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 north west 60th avenue; miami lakes FL 33014
• MDR Report Key: 7604841
• Report Number: 7604841
• Device Sequence Number: 19256182
• Product Code: NIP
• UDI-Device Identifier: 20705032025055
• UDI-Public: (01)20705032025055
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018
• Report Date (Section F): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: C14080SB
• Device Catalogue Number: C14080SB
• Device Lot Number: 17724432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO OTHER THERAPIES
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 90
• Date Report Sent to FDA: 06/13/2018