FDA Adverse Event
Death
Summary report: N
BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE
MDR report key: 525264
·
Received May 13, 2004
Report
- Report Number
- 6000012-2004-00006
- Event Type
- Death
- Date Received
- May 13, 2004
- Date of Event
- January 22, 2004
- Report Date
- April 19, 2004
- Manufacturer
- SHILEY, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE INITIAL REPORTER ADVISED SHIELY INC. OF THE DEATH OF A PT FOLLOWING AN ALLEGED OUTLET STRUT FRACTURE OF THE PT'S BJORK-SHILEY CONVEXO-CONCAVE MITRAL HEART VALVE. ACCORDING TO A COPY OF THE PATHOLOGY REPORT SUBSEQUENTLY FORWARDED TO SHILEY INC. FROM THE PT'S SPOUSE, "THE DISCOID CIRCULAR LEAFLET IS ABSENT AND THE STRUTS APPEAR BROKEN". A "MITAL VALVE PROSTHESIS MALFUNCTION" IS LISTED AS AN UNDERLYING CAUSE ON THE DEATH CERTIFICATE, WHICH WAS ALSO FORWARDED TO SHILEY INC. FROM THE PT'S SPOUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BJORK-SHILEY 60 DEGREE CONVEXO-CONCAVE | HEART VALVE | LWQ | SHILEY, INC. | 29EMBRC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Death| H| L |