BOSTON SCIENTIFIC SYNERGY
Received Dec 1, 2022 · Event occurred Nov 28, 2022
Report MW5113583 · MDR key 15906168
Device
Generic name
Coronary Drug-eluting Stent
Lot number
28266143
Product problems
- Material Frayed
Patient
81 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
AN 81-YEAR-OLD MALE WITH PAST MEDICAL HISTORY GUILLAIN-BARRE, CAD (CORONARY ARTERY DISEASE HYME PRESENT ASTHMA, PAROXYSMAL ATRIAL FIBRILLATION ADMITTED WITH CHEST PAIN. UPON EVALUATION THE PATIENT WAS NOTED TO BE A NSTEMI. FOR CARDIAC CATHETERIZATION WITH CIROMAY ANGIOGRAM AND POSSIBLE STENT PLACEMENT. ON (B)(6) 2022 CARDIAC CATHETERIZATION WAS PERFORMED UTILIZING A 2.75 X 16 MM BOSTON SYNERGY XD. DURING WITHDRAWAL MULTIPLE STRANDS OF STENT MATERIAL CAME FREE AND REMAIN IN THE PATIENT, POSSIBLY THE AORTA. USING MICRO ENSNARE SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE FRAYING OBJECT BUT WERE UNSUCCESSFUL.