FDA Adverse Event
Death
Summary report: N
COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
MDR report key: 1051814
·
Received May 22, 2008
Report
- Report Number
- 6000002-2008-07295
- Event Type
- Death
- Date Received
- May 22, 2008
- Date of Event
- January 11, 2008
- Report Date
- January 31, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, PT EXPIRED APPROXIMATELY AFTER AN IMPLANT DURATION OF 0 DAYS, DUE VENTRICULAR LACERATION. PHYSICIAN STATED THE DEVICE WAS NOT ASSOCIATED WITH PT DEATH. DEVICE NOT EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 460028MM | R07K1959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |