FDA Adverse Event
Death
Summary report: N
SJM EPIC STENTED PROCINE HEART VALVE
MDR report key: 1656766
·
Received April 9, 2010
Report
- Report Number
- 3001743903-2010-00025
- Event Type
- Death
- Date Received
- April 9, 2010
- Date of Event
- March 26, 2010
- Report Date
- April 9, 2010
- Manufacturer
- ST. JUDE MEDICAL BRASIL LTDA.
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, DURING THE IMPLANT PROCEDURE AND AFTER THIS VALVE WAS IMPLANTED, AN AORTIC INSUFFICIENCY WAS DETECTED AND THE VALVE WAS REMOVED AND REPLACED WITH A SMALLER 19 MM SJM MECHANICAL VALVE (MEDWATCH REPORT# 3001743903-2010-00026). THE PT DIED THE SAME DAY AS THE PROCEDURE. THE CAUSE OF DEATH IS UNK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SJM EPIC STENTED PROCINE HEART VALVE | STENTED TISSUE VALVE | LWR | ST. JUDE MEDICAL BRASIL LTDA. | E100-21A-00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death |