FDA Adverse Event
Injury
Summary report: N
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
MDR report key: 5148575
·
Received October 14, 2015
Report
- Report Number
- 2015691-2015-02736
- Event Type
- Injury
- Date Received
- October 14, 2015
- Date of Event
- September 18, 2015
- Report Date
- September 18, 2015
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P130009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
AS REPORTED, 15 DAYS POST DEPLOYMENT OF A 26MM SAPIEN XT VALVE THE PATIENT WAS READMITTED TO THE HOSPITAL WITH CHF. DURING THE ADMISSION AN ECHO REVEALED THE PATIENT HAD SEVERE AORTIC INSUFFICIENCY. A BAV WAS PERFORMED WITH A 25MM BALLOON. NO REDUCTION IN AI WAS NOTED. THE DECISION WAS THEN MADE TO DEPLOY A SECOND VALVE. A SECOND 26MM SAPIEN S3 WAS IMPLANTED LEAVING WITH THE PATIENT WITH NONE/TRACE AI VIA ECHO AND ANGIOGRAPHY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679894 | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9300TFX26 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |