EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM Adverse Event — Death (MDR 2134265-2008-00471)
EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM Adverse Event — Death (MDR 2134265-2008-00471) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM; Generic name: MAF STENT, CORONARY; Manufacturer: BOSTON SCIENTIFIC CORPORATION.
| Device | EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM |
|---|---|
| Generic name | MAF STENT, CORONARY |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Report number | 2134265-2008-00471 |
| Event type | Death |
| Product problem | N |
| Date received | 2008-02-19 |
| Report source | Foreign, Study, Health Professional, User facility |
| Narrative | CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT DIED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 66.6% STENOSIS, A LENGTH OF 26 MM AND A REFERENCE VESSEL DIAMETER OF 2.8 MM. THE PHYSICIAN PRE-DILATED THE LESION AND PLACED A 3.0 X 32 MM EXPRESS2 BARE METAL STENT. PROCEDURAL SUCCESS WAS OBTAINED WITH LESS THAN 30% RESIDUAL STENOSIS. THE PT W |
| Source | openFDA MAUDE (device adverse events) |
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