D
Patient 1
IN 2006, THIS PT WAS IMPLANTED WITH THREE GORE TAG THORACIC ENDOPROSTHESES. IN 2008, THIS PT HAD A RE-INTERVENTION TO REPAIR A RUPTURED ANEURYSM. IMAGES HAVE BEEN SENT TO GORE. FURTHER INVESTIGATION IS BEING CONDUCTED.
MAUDE MDR 1165673
- MDR report key
- 1165673
- Report number
- 2017233-2008-00622
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-05-28
- Date received
- 2008-09-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JASON CURETON
- Address
- 3450 WEST KILTIE LANE FLAGSTAFF AZ 86001 US
- Phone
- 925-925-9258
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GORE TAG THORACIC ENDOPROSTHESIS | NONE | W.L. GORE & ASSOCIATES | MIH | WLG326 | TG3710 | 03615150 | Y | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-09-18 | 0 | 1. R |