FDA Adverse Event
Injury
Summary report: N
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
MDR report key: 1233912
·
Received November 13, 2008
Report
- Report Number
- 6000002-2008-09277
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- June 30, 2007
- Report Date
- October 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P000007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROXIMATELY AFTER AN IMPLANT DURATION OF 104 MONTHS, DUE TO UNK REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2500P | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |