inforMED
InjuryNCA

SYMMETRY

Received Jul 8, 2003

Report MW1028949 · MDR key 471395

Device

Generic name

*

Manufacturer

*

Model number

*

Catalog number

*

Lot number

*

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.