FDA Adverse Event
Other
Summary report: N
CARDIOSEAL OCL-028-VSD
MDR report key: 308865
·
Received December 15, 2000
Report
- Report Number
- 1222632-2000-00011
- Event Type
- Other
- Date Received
- December 15, 2000
- Date of Event
- November 14, 2000
- Report Date
- December 7, 2000
- Manufacturer
- NMT MEDICAL, INC.
- Product Code
- MLV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
POST IMPLANTATION, 38 DAYS LATER, THE PT UNDERWENT A TEE PROCEDURE DURING WHICH A THROMBUS FORMATION WAS NOTED ON THE LEFT ATRIAL DISC OF THE DEVICE. PT IS POSITIVE FOR CARDIOLIPIN ANTIBODY AND WAS ON A COUMADIN REGIMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIOSEAL OCL-028-VSD | CARDIOSEAL | MLV | NMT MEDICAL, INC. | OCL-028-PFO | 0006120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |