ST JUDE MEDICAL
Received Apr 10, 2002 · Event occurred Feb 27, 2002
Report 390877 · MDR key 390877
Device
Generic name
Symmetry Bypass System (nitinol Aortic Connector)
Manufacturer
St Jude MedicalModel number
ACN 4550Catalog number
GRAY COLOR CODE
Lot number
*
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
75 YR
- Bleeding
- Cardiopulmonary Arrest
- Death
Narrative
Description of Event or Problem
PT RETURNED TO OR WITH COPIOUS BLEEDING INTO MEDIASTINUM POST-OP DAY #2 STATUS POST CAB6X4. BLEED NOTED AT RIGHT-SIDED (PDA) GRAFT PROXIMAL SITE AND SYMMETRY CONNECTOR (ACN 4550) APPEARED TO BE INTACT. IT WAS UNCLEAR WHETHER THE BLEEDING WAS DUE TO FRIABLE AORTA AT THIS SITE OR A DEFECT IN THE SAPHENOUS VEIN GRAFT ITSELF. REPAIR SUCCESSFUL. PT RECEIVED MULTI UNITS PACKED CELLS. POST-OP DAY #4 (2) WHILE ELEVATED BUN AND CREATINE AND POSSIBLE SEPTIC PICTURE, PT ARRESTED. AUTOPSY SHOWED AORTIC PATCH INTACT, POSSIBLE THROMBUS TO ALOM AND PDA GRAFTS, AND COMPLETE DEHISCENCE OF PROXIMAL ANASTOMOSIS OF PLOM GRAFT LIKELY DUE TO RESUSCITATION EFFORTS.