MAUDE MDR 52976
- MDR report key
- 52976
- Report number
- 2025240-1996-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 1969-12-31
- Date received
- 1996-11-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | PRECLUDED IMA SLEEVE | IMA SLEEVE | W.L. GORE ASSOCIATES, INC. | MFX | UNK | UNK | UNK | | | N | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 1996-11-27 | 0 | 1. R
|
Event Narratives
D
Patient 1
AFTER IMPLANTING THE IMA SLEEVE, THE DR. FOUND BLOOD CLOTTING BETWEEN THE PEDICLE AND SLEEVE, RESULTING IN COMPRESSION OF THE PEDICLE AND REDUCED BLOOD FLOW THROUGH THE PEDICLE. THE DR WENT BACK, CUT OPEN THE SLEEVE AND CLEARED THE CLOT FORMED THERE.
Related GUDID Devices By Product Code
No records found.
Related PMN/PMA Records By Product Code
| Type | Submission | Product code | Device | Applicant | Decision date |
|---|
| 510(k) | K061727 | MFX | GORE PRECLUDE VESSEL GUARD | W. L. Gore & Associates, Inc. | 2006-08-07 |
| 510(k) | K960532 | MFX | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | 1996-05-23 |