FDA Adverse Event
Injury
Summary report: N
SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS
MDR report key: 3190134
·
Received June 21, 2013
Report
- Report Number
- 2648612-2013-00028
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- May 13, 2013
- Report Date
- June 6, 2013
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- LWQ
- PMA / PMN Number
- P810002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PATIENT WEIGHT NOT PROVIDED FROM THE SITE.SOFTWARE INVESTIGATION IS CURRENTLY IN PROGRESS, RESULTS NOT AVAILABLE AT TIME OF THIS REPORT.
Description of Event or Problem · 1
THE PT PRESENTED WITH DYSPNEA AND AN ELEVATED GRADIENT AND EXAMS SHOWED THAT ONE LEAFLET WAS IMPEDED. THE VALVE WAS EXPLANTED AND REPLACED WITH A SMALLER 19 MM ATS VALVE. THE PT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE SURGERY; HOWEVER, THE NEW AORTIC VALVE ALSO DEMONSTRATES AN ELEVATED GRADIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283122 | SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS | STANDARD HEART VALVE | LWQ | ST. JUDE MEDICAL | 21AHP-105 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |