FDA Adverse Event
Death
Summary report: N
WIKTOR CORONARY STENT DELIVERY SYSTEM
MDR report key: 122253
·
Received September 23, 1997
Report
- Report Number
- 2083093-1997-00050
- Event Type
- Death
- Date Received
- September 23, 1997
- Date of Event
- August 25, 1997
- Report Date
- September 19, 1997
- Manufacturer
- MEDTRONIC INTERVENTIONAL VASCULAR, INC.
- Product Code
- MAF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON 10/1/97, MEDTRONIC LEARNED THAT THE PT HAD EXPIRED THE DAY AFTER THE PROCEDURE, 8/26/97.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIKTOR CORONARY STENT DELIVERY SYSTEM Implant | CORONARY STENT DELIVERY SYSTEM | MAF | MEDTRONIC INTERVENTIONAL VASCULAR, INC. | 6570 | J97224910 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death| R |