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

Model Number C10080SB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Perforation (2001); Extubate (2402)

Event Date 11/22/2019

Event Type  Death  

Event 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.
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 n.w. 60th ave.; miami lakes FL 33014
• MDR Report Key: 9804981
• MDR Text Key: 182554343
• Report Number: 9804981
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 20705032024690
• UDI-Public: (01)20705032024690
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C10080SB
• Device Catalogue Number: C10080SB
• Device Lot Number: 17726139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20075 DA
• Patient Weight: 83