FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1181647
·
Received September 29, 2008
Report
- Report Number
- 6000002-2008-08801
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 9, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE MAGNA VALVE WAS IMPLANTED DUE TO THE AORTIC REGURGITATION. PATIENT ALSO HAD AORTIC DISSECTION. AT THE IMPLANT, CUSTOMER WONDERED IF THE VALVE FIT THE ANNULUS RIGHT AND DECIDED TO RE-SEW. AT THE RE-SEWING, DAMAGE WAS FOUND ON THE SEWING RING OF MAGNA VALVE. CUSTOMER DECIDED TO IMPLANT DEVICE WHICH IS THE MODEL THE CUSTOMER WAS USING BEFORE. CUSTOMER COMMENTED THAT THEY USE THICKER SUTURES (1-0) THAN THE ONES OTHER FACILITIES NORMALLY USE AND IT DID NOT SEEM THERE WAS A PROBLEM WITH THE VALVE. THERE WILL BE NO PRODUCT RETURN, AS THE DEVICE WAS DISCARDED.
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 | 78 YR | Hospitalization| R |