[247248]
Complainant reported late stent thrombosis in a brachytherapy pt with no new stent. A six-month-old restenosed stent was radiated using the beta-cath system. Because of a gastro-intestinal bleed, asa and plavix were discontinued at an outside hosp. Two weeks later the pt thrombosed and had to be given primary angioplasty. Pt had to be given primary angioplasty to treat the thrombus formation. Pt recovered. Current product instructions for use specify "antiplatelet therapy recommendations" in "section iii. Essential prescribing information". Additionally, clinical results supporting the need for antiplatelet therapy are also included in the product instructions for use. Pts that cannot be administered antiplatelet and/or anticoagulant therapy due to pre-existing conditions should not be considered for treatment with vascular brachytherapy. The product instructions for use further specify late stent thrombosis and thrombotic occlusions as potential adverse events associated with percutaneous coronary interventions. No further design, mfg, labeling, or therapy changes are proposed at this time. There is no follow-up report anticipated at this time. This is an isolated occurrence. Product should be used in accordance with labeling restrictions. No corrective action is planned at this time. Beta-cath system product instructions for use contain the necessary and appropriate info to successfully treat pts with vascular brachytherapy while minimizing pt and user safety risks. Product complaints will continue to be reviewed on a monthly basis, at a minimum, for similar occurrences or trends of adverse events.
Patient Sequence No: 1, Text Type: D, B5