FDA Adverse Event
Death
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1131766
·
Received August 21, 2008
Report
- Report Number
- 6000002-2008-08495
- Event Type
- Death
- Date Received
- August 21, 2008
- Date of Event
- June 25, 2008
- Report Date
- July 30, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOW-OUTPUT SYNDROME; CARDIAC ARREST. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED, AFTER AN IMPLANT DURATION OF ONE DAY, DUE TO LOW-OUTPUT SYNDROME AND TO CARDIAC ARREST. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4450, WAS IMPLANTED. REFER TO MFR #6000002-2008-08494. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4900 | R08B0345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |