FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 3181149
·
Received June 21, 2013
Report
- Report Number
- 2015691-2013-20391
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- May 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE NOT RETURNED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. NO DOCUMENTATION OR TESTING RESULTS ARE INDICATED AS AVAILABLE. NO ECHO IS AVAILABLE. THE DEVICE HISTORY RECORD (DHR) REVIEW IS IN PROCESS.
Description of Event or Problem · 1
REPORTEDLY, PATIENT UNDERWENT VALVE-IN-VALVE PROCEDURE ON (B)(6) 2013 TO CORRECT REGURGITATION (GRADE III), STENOSIS AND SHORTNESS OF BREATH. THE CUSTOMER REPORTED THAT A MODEL 6900P WAS IMPLANTED FOR APPROXIMATELY 9 YEARS (108.63 MONTHS) AT TIME OF THE PROCEDURE. DEVICE REMAINS IMPLANTED. PATIENT STATUS INDICATED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282133 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | HEART-VALVE, REPLACEMENT | DYE | EDWARDS LIFESCIENCES | 6900P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |