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

Model Number	C10080SB
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Perforation (2001); Extubate (2402)
Date of Event	11/22/2019
Type of Reportable Event	Death
Event or Problem Description
Middle-aged female underwent a cardiac catherization utilizing cutting balloon catheter to restore flow to existing stent re-stenosis.The procedure was complicated by an ellis type iii perforation requiring emergent pericardiocentesis, pigtail drain placement, prolonged intracoronary balloon inflation to control bleeding into the pericardium, and covered stent placement for final stabilization of the artery.Patient arrested during procedure, requiring several rounds of cpr, intubation / mechanical ventilation, high dose inotropic support and intra-aortic balloon pump (iabp) placement to achieve stabilization.Patient was transferred to the icu where she endured another cardiac arrest and unfortunately expired.

• Brand Name: S.M.A.R.T.
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 9804981
• Report Number: 9804981
• Device Sequence Number: 2921793
• Product Code: NIP
• UDI-Device Identifier: 20705032024690
• UDI-Public: (01)20705032024690
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2020
• Report Date (Section F): 02/28/2020

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: Health Professional
• Device Model Number: C10080SB
• Device Catalogue Number: C10080SB
• Device Lot Number: 17726139
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 83
• Date Report Sent to FDA: 02/28/2020