FDA Adverse Event
Injury
Summary report: N
HEARTMATE VE LVAS
MDR report key: 212611
·
Received March 2, 1999
Report
- Report Number
- 1218444-1999-00003
- Event Type
- Injury
- Date Received
- March 2, 1999
- Date of Event
- February 1, 1999
- Report Date
- February 2, 1999
- Manufacturer
- THERMO CARDIOSYSTEMS, INC.
- Product Code
- DSQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON 02/01/1999, FOR BLEEDING. ON REEXPLORATION, THE PATIENT WAS FOUND TO BE BLEEDING FROM THE SUPERIOR EPIGASTRIC ARTERY. THE SURGEONS HAD INFORMED THE LEFT VENTRICULAR ASSIST DEVICE COORDINATOR THAT THEY THINK THE ARTERY WAS ERODED BY ONE OF THE EYELETS ON THE HOUSING OF THE LEFT VENTRICULAR ASSIST DEVICE. THE LEFT VENTRICULAR ASSIST DEVICE COORDINATOR STATED THAT THE SURGEONS DO NOT SECURE THE LEFT VENTRICUALR ASSIST DEVICE IN INTRAPERITONEAL PLACEMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE VE LVAS Implant | LEFT VENTRICULAR ASSIST DEVICE | DSQ | THERMO CARDIOSYSTEMS, INC. | 1212 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Life Threatening| R |