FDA Adverse Event
Death
Summary report: N
AMPLATZER
MDR report key: 1663288
·
Received April 14, 2010
Report
- Report Number
- 1663288
- Event Type
- Death
- Date Received
- April 14, 2010
- Date of Event
- November 18, 2008
- Report Date
- November 20, 2008
- Manufacturer
- AGA MEDICAL CORPORATION
- Product Code
- MLV
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PATIENT HAD A SEPTAL OCCLUDER PLACED AND RETURNED THE FOLLOWING DAY TO THE CARDIOVASCULAR (CV) LAB DUE TO THE OCCLUDER DISLODGMENT INTO THE LEFT VENTRICLE OF THE HEART. RETRIEVAL ATTEMPTED FOR 3 HOURS. PATIENT TAKEN EMERGENTLY TO OR FOR REMOVAL AND EXPIRED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMPLATZER | TRANSCATHETER SEPTAL OCCLUDER | MLV | AGA MEDICAL CORPORATION | * | M08G24-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Death | CARDIAC DRUGS |