SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM
Received Aug 13, 2007 · Event occurred Aug 20, 2001
Report 2135392-2007-00002 · MDR key 893127
Device
Generic name
Aortic Connector
Manufacturer
St. Jude Medical Atg, Inc.Model number
ACN-UNKNOWNCatalog number
ACN-UNKNOWN
Product problems
- Device remains implanted
Patient
49 YR
- Failure of Implant
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT HAD A SIGNIFICANT HISTORY OF ISCHEMIC CAD AND PREVIOUS INTERVENTION IN 2001, (STENTING AND ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL-D1, WITH IN-STENT RESTENOSIS OF THE ANGIOPLASTY SITE). APPROX THREE MONTHS LATER, THE PATIENT UNDERWENT OFF-PUMP CABG X3 WITH THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD, AND A SJM SYMMETRY CONNECTOR WAS UTILIZED FOR THE SAPHENOUS VEIN GRAFT (SVG) TO THE D1. APPROX TWO MONTHS LATER, THE PATIENT EXPERIENCED EARLY SVG FAILURE AND UNDERWENT COMPLEX INTERVENTION. THE SVG TO THE D1 WAS PATIENT, BUT SEVERELY DISEASED AT THE PROXIMAL AND DISTAL ANASTOMOTIC AREAS AND WAS STENTED. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY.