ETHIBOND EXCEL POLYESTER SUTURE 2-0
Received Jul 27, 2009 · Event occurred Jul 13, 2009
Report 1424017 · MDR key 1424017
Device
Generic name
Ethicon Suture
Manufacturer
Ethicon, Inc.Model number
NACatalog number
PXX92.032
Lot number
AGB097
Product problems
- Defective Device
Patient
87 YR
- Hemorrhage/Blood Loss/Bleeding
- Surgical procedure, additional
Narrative
Description of Event or Problem
IN 2009 - PT FOR AORTIC VALVE REPLACEMENT WITH A 21-MM HANCOCK AORTIC VALVE PROSTHESIS, AND IN PROCESS OF SUTURING VALVE, SUTURE BROKE. PHYSICIAN DOCUMENTED: "THIS WAS SUTURED IN PLACE USING INTERRUPTED 2-0 PLEDGETED ETHIBOND SUTURES. AS WE WERE TYING DOWN THE SUTURES, APPROXIMATELY 2/3 OF THE WAY THROUGH, ONE OF THEM BROKE AND IT WAS JUST UNDER THE ORIFICE OF THE RIGHT CORONARY ARTERY. THIS NECESSITATED REMOVING THE SUTURES THAT HAD BEEN PLACED TO FIX THIS LEAK. IN DOING SO, WE WERE CONCERNED ABOUT THE SEWING RING OF THE VALVE. THEREFORE, THIS VALVE WAS REPLACED WITH ANOTHER ONE, AND THIS WAS A 21-MM HANCOCK 2 AORTIC VALVE PROSTHESIS AND THIS WAS SUTURED IN PLACE USING INTERRUPTED 2-0 ETHIBOND SUTURES. THESE WERE ALSO PLEDGETED AND THE VALVE SEATED WELL AND WE HAD WHAT WE FELT WAS A GOOD FIT. AFTER ALL THE SUTURES WERE TIED, WE INSPECTED THIS AREA. THE VALVE LEAFLETS MOVED WELL, AND THE SEWING RING WAS SEATED IN THE ANNULUS VERY WELL." PT TRANSFERRED OUT TO SICU IN STABLE CONDITION AND ULTIMATELY DISCHARGED FOUR DAYS LATER, TO REHAB HOSP.