FDA Adverse Event
Death
Summary report: N
PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT
MDR report key: 59144
·
Received December 17, 1996
Report
- Report Number
- 2247023-1996-00145
- Event Type
- Death
- Date Received
- December 17, 1996
- Date of Event
- December 4, 1996
- Report Date
- December 4, 1996
- Manufacturer
- NEW JERSEY PLANT
- Product Code
- MAF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S CIRCUMFLEX ARTERY. THE LEFT MAIN ARTERY WAS DISSECTED. THE DR REPORTED THAT THE TUOHY-BORST VALVE WOULD NOT REMAIN SECURE. VENTRICULAR FIBRILLATION OCCURRED DOPAMINE AND EPINEPHRINE WERE ADMINISTERED. THE PT WAS CARDIOVERTED AND PLACED ON AN INTRA-AORTIC BALLOON PUMP. THE PT WAS SENT TO EMERGENT CABG AND SUBSEQUENTLY EXPIRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT Implant | CORONARY STENT WITH DELIVERY SYSTEM | MAF | NEW JERSEY PLANT | NA | 119528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |