inforMED
InjuryNCA

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

Model number

ACN-UNKNOWN

Catalog 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.