MAUDE MDR 1085759
- MDR report key
- 1085759
- Report number
- 6000002-2008-08302
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-07-22
- Date received
- 2008-08-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact
- Contact
- NEIL LANDRY
- Address
- ONE EDWARDS WAY IRVINE CA 92614 US
- Phone
- 949-949-9492
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | EDWARDS PERICARDIAL PATCH | PERICARDIAL PATCH | EDWARDS LIFESCIENCES | MFX | 4700 | NA | UNK | | | Y | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2008-08-01 | 0 | 1. D
|
Event Narratives
D
Patient 1
IT WAS REPORTED THAT THE PATIENT EXPIRED IN 2008, AFTER AN IMPLANT DURATION OF .02 MOS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #6900PTFX, WAS IMPLANTED. REFER TO MFR #6000002-2008-08305. A THIRD DEVICE WAS ALSO EXPLANTED, MODEL #6900PTX. REFER TO MFR #6000002-2008-07886.
N
Patient 1
DEVICE NOT RETURNED.
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 |