FDA Adverse Event
Injury
Summary report: N
GORE INTERING VASCULAR GRAFT
MDR report key: 3489337
·
Received November 15, 2013
Report
- Report Number
- 2017233-2013-00736
- Event Type
- Injury
- Date Received
- November 15, 2013
- Date of Event
- November 4, 2013
- Report Date
- November 4, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K991602
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF DEVICE MFR RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS. ATTEMPTS TO OBTAIN THE INFORMATION REQUIRED FOR THIS FORM WAS MADE BY W.L. GORE & ASSOCIATES, INC.
Description of Event or Problem · 1
ON (B)(6) 2013, GORE-TEX INTERING STRETCH VASCULAR GRAFT WAS IMPLANTED IN A FEMORO-FEMORAL PROCEDURE. ON (B)(6) 2013, THE PATIENT TRIPPED AND FELL WHILE STILL RECOVERING AT THE HOSPITAL. THE PATIENT THEN PRESENTED WITH A HEMATOMA AT THE GROIN. DURING THE REVISION PROCEDURE, THE PHYSICIAN PLACED AN INTERPOSITION GRAFT. TWO CENTIMETERS OF GORE-TEX INTERING STRETCH VASCULARE GRAFT WAS TORN NEAR THE ANASTOMOSIS. THE PATIENT IS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593255 | GORE INTERING VASCULAR GRAFT | DSY/PROSTHESIS, VASCULAR GRAFT | DSY | W.L. GORE & ASSOCIATES | 11080281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |