SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM
Received Aug 13, 2007 · Event occurred Aug 20, 2001
Report 2135392-2007-00003 · MDR key 893126
Device
Generic name
Aortic Connector
Manufacturer
St. Jude Medical Atg, Inc.Model number
ACN-UNKNOWNCatalog number
ACN-UNKNOWN
Product problems
- Occlusion Within Device
- Device remains implanted
Patient
49 YR
- Reocclusion
- 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 A SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL BRANCH (OMB). APPROX TWO MONTHS LATER,, THE PATIENT EXPERIENCED EARLY SVG FAILURE AND UNDERWENT COMPLEX INTERVENTION. THE SVG TO THE OMB WAS TOTALLY OCCLUDED AND WAS STENTED. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY.