MalfunctionGAS
COR-KNOT
Received Dec 24, 2013 · Event occurred Dec 23, 2013
Report MW5033614 · MDR key 3542256
Device
Product problems
- Separation Failure
Patient
52 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
LDI SOLUTIONS COR-KNOT DEVICE WOULD NOT RELEASE AFTER ACTIVATING. SECOND DEVICE FROM PACKAGE UTILIZED FOR REMAINDER OF SECUREMENTS. DIAGNOSIS OR REASON FOR USE: MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT.