FDA Adverse Event
Death
Summary report: N
GORE-TEX VASCULAR GRAFT
MDR report key: 1308550
·
Received February 5, 2009
Report
- Report Number
- 2017233-2009-00049
- Event Type
- Death
- Date Received
- February 5, 2009
- Report Date
- February 4, 2009
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
1SHUNJI S, HUANG SC, KASAHARA S. RISK FACTORS FOR MORTALITY AFTER THE NORWOOD PROCEDURE USING RIGHT VENTRICLE TO PULMONARY ARTERY SHUNT. THE ANNALS OF THORACIC SURGERY. 2009;87:178-86.
Description of Event or Problem · 1
IN THE MEDICAL LITERATURE, A RECENT ARTICLE TITLED, "RISK FACTORS FOR MORTALITY AFTER THE NORWOOD PROCEDURE USING RIGHT VENTRICLE TO PULMONARY ARTERY SHUNT,"1 WAS REVIEWED. THIS STUDY WAS PERFORMED ON PTS WITH HYPOPLASTIC LEFT HEART SYNDROME (HLHS). BETWEEN 1998 AND 2007, GORE TEX VASCULAR GRAFTS CONFIGURED FOR PEDIATRIC SHUNTS WERE IMPLANTED IN A TOTAL PTS. A LATE DEATH WAS REPORTED DUE TO SHUNT OBSTRUCTION. FURTHER INVESTIGATION IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE-TEX VASCULAR GRAFT | NONE | DSY | W.L. GORE & ASSOCIATES | WLG250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |