FDA Adverse Event
Injury
Summary report: N
REPLACEMENT HEART VALVE
MDR report key: 3873069
·
Received June 13, 2014
Report
- Report Number
- 2015691-2014-01389
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 19, 2014
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THIS EVENT HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THIS EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
EDWARDS RECEIVED INFORMATION THAT AN EDWARDS DEVICE WAS EXPLANTED AFTER AN UNKNOWN IMPLANT DURATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED THE REASON FOR EXPLANT REMAINS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349249 | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |