FDA Adverse Event
Injury
Summary report: N
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
MDR report key: 3161553
·
Received May 5, 2013
Report
- Report Number
- 2017233-2013-00356
- Event Type
- Injury
- Date Received
- May 5, 2013
- Date of Event
- August 11, 2009
- Report Date
- May 9, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES,INC
- Product Code
- DYB
- PMA / PMN Number
- K032073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG RECORDS FOR THE DEVICE IS BEING CONDUCTED ON THE DEVICE.
Description of Event or Problem · 1
ON (B)(6) 2009, THIS PATIENT WAS IMPLANTED WITH TWO GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A THORACIC AORTIC DISSECTION. A GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE WAS INSERTED FROM THE RIGHT EXTERNAL ILIAC ARTERY AND THE TAG DEVICES WERE SUCCESSFULLY IMPLANTED. WHEN THE SHEATH WAS WITHDRAWN FROM THE PATIENT'S VASCULATURE, THE PHYSICIAN DETERMINED A DISSECTION OF THE EXTERNAL ILIAC ARTERY. A S.M.A.R.T. VASCULAR STENT WAS IMPLANTED TO SUCCESSFULLY REPAIR THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196029 | GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE | DYB/INTRODUCER, CATHETER | DYB | W.L. GORE & ASSOCIATES,INC | 06584896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| O |