FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1212265
·
Received October 17, 2008
Report
- Report Number
- 6000002-2008-08993
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- January 7, 2008
- Report Date
- September 22, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057S018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED 4 WEEKS POST OPERATIVELY, BECAUSE THE PT DEVELOPED BACTEREMIA WITH ACHROMOBACTER XYLOSOXIDANS, AND REQUIRED RE-DO VALVE REPLACEMENT. THIS INFO WAS PROVIDED BY THE FDA. TWO CALLS WERE MADE ON 10/3/2008 TO F/U WITH THE PHYSICIAN TO OBTAIN ADD'L INFO; HE WAS OUT OF THE OFFICE. ON 10/16/2008, THE PHYSICIAN'S ANSWERING SVC INDICATED THAT A REQUEST FOR ADD'L INFO BE FAXED AS THE PHYSICIAN WAS UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 3000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Life Threatening| R |