SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM
Received Oct 24, 2007 · Event occurred Feb 20, 2003
Report 2135392-2007-00004 · MDR key 931648
Device
Generic name
Aortic Connector
Manufacturer
St. Jude Medical Atg, IncModel number
ACN-UNKCatalog number
ACN-UNK
Product problems
- Device remains implanted
Patient
63 YR
- Chest Pain
- High Blood Pressure/ Hypertension
- Occlusion
- Breathing difficulties
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
ACCORDING TO INFORMATION RECEIVED, THE PT UNDERWENT CABG X2. A SAPHENOUS VEIN GRAFT (SVG) WAS GRAFTED TO THE RAMUS INTERMEDIUS UTILIZING A SJM SYMMETRY AORTIC CONNECTOR PROXIMALLY FOR THE ATTACHMENT TO THE AORTA, AND THE LEFT INTERNAL MAMMARY ARTERY (LIMA) WAS GRAFTED TO THE LEFT ANTERIOR DESCENDING (LAD). APPROX 7 MONTHS POSTOPERATIVELY, THE PT DEVELOPED SOB AND CHEST PAIN. CARDIAC CATHETERIZATION WAS PERFORMED AND DEMONSTRATED THE RAMUS INTERMEDIUS BRANCH WAS OCCLUDED PROXIMALLY AND THE LIMA WAS OCCLUDED. PTCA WAS PERFORMED AND A STENTS WERE PLACED IN THE RAMUS INTERMEDIUS BRANCH OF THE LEFT CIRCUMFLEX (CX) AND THE LAD. THE PT SUBSEQUENTLY UNDERWENT ADDITIONAL CARDIAC CATH PROCEDURES FOR OCCLUSION OF THE SVG AND LIMA. IN 2006, THE PT UNDERWENT HEART CATHETERIZATION FOR COMPLAINTS OF CHEST PAIN, WAS DIAGNOSED WITH PULMONARY HYPERTENSION AND WAS DISCHARGED IN STABLE CONDITION.