MalfunctionOVN
DEKNATEL TEV TRI BR 2-0 KT-3 30"X9 PFM
Received Nov 4, 2014 · Event occurred Sep 5, 2014
Report 3004365956-2014-00383 · MDR key 4240081
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINT ALLEGES: IT WAS REPORTED THAT DURING AN AORTIC VALVE REPLACEMENT PROCEDURE, WHILE TYING THE STITCHES DOWN, THEY BROKE. THE SURGEON REPLACED THE SUTURES AND FINISHED THE CASE. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT IS IN STABLE CONDITION.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD (DHR) SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO MANUFACTURER'S SPECIFICATIONS. DEVICE SAMPLE RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.