SYMMETRY
Received Jul 8, 2003
Report MW1028949 · MDR key 471395
Product problems
- Device Maintenance Issue
Patient
65 YR
- Death
- Myocardial Infarction
- Surgical procedure
Narrative
Description of Event or Problem
MULTIPLE PTS IN THE REPORTER'S AND SURROUNDING INSTITUTIONS HAVE HAD CORONARY BYPASS SURGERY WITH A SYMMETRY DEVICE USED TO ATTACH THE VEIN GRAFT TO THE AORTA. SEVERAL HAVE HAD POST OPERATIVE MYOCARDIAL INFARCTION AND RE-CATHETERIZATION REVEALS DEVICE CLOSURE RESULTING IN GRAFT LOSS. REPORTER KNOW'S PERSONALLY OF TWO PT DEATHS RELATED TO THIS. THERE ARE OTHER PTS WITH MI AND OTHERS WHO HAVE REQUIRED REOPERATION WITHIN MONTHS TO CORRECT THIS GRAFT LOSS. ON RE-CATH, REPORTER HAS SEEN ONLY ONE OF PROBABLY 30 SYMMETRY DEVICES THAT HAVE PATENCY. THIS INCLUDED PTS OPERATED ON AT FOUR DIFFERENT INSTITUTIONS BY DIFFERENT SURGEONS. REPORTER CAN'T IMAGINE THIS IS A UNIQUE EXPERIENCE.