FDA Adverse Event
Death
Summary report: N
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING
MDR report key: 1031074
·
Received April 17, 2008
Report
- Report Number
- 6000002-2008-06573
- Event Type
- Death
- Date Received
- April 17, 2008
- Date of Event
- February 23, 2008
- Report Date
- April 7, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTABLY, PT EXPIRED DUE TO UNK REASONS. UNK IF DEATH IS DEVICE RELATED. IMPLANT DURATION WAS ONE DAY. PT ALSO HAD A 4900 IMPLANTED IN THE TRICUSPID POSITION ON THE SAME DAY. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4100 | R-07G1436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |