inforMED
InjuryNCA

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

Model number

ACN-UNKNOWN

Catalog 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.