FDA Adverse Event
Injury
Summary report: N
ARTEGRAFT COLLAGEN VASCULAR GRAFT
MDR report key: 3031104
·
Received July 3, 2006
Report
- Report Number
- 2247686-2006-00003
- Event Type
- Injury
- Date Received
- July 3, 2006
- Date of Event
- June 1, 2006
- Report Date
- July 3, 2006
- Manufacturer
- ARTEGRAFT, INC.
- Product Code
- LXA
- PMA / PMN Number
- N16837
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF RECENT COMPLAINT/MDR RECORDS DO NOT REFLECTED ONE SIGNIFICANT SIMILAR INCIDENTS OF SEROMA-BASED INJURY OR INTERVENTIONS. ARTEGRAFT DOES REVIEW COMPLAINT TRENDING FOR SIMILAR TYPES OF PROBLEMS AND ISSUES ON A PERIODIC BASIS. THIS WILL CONTINUE.
Description of Event or Problem · 1
A SEROMA, A COLLECTION OF SERUM OR BLOOD FLUID IN THE SURROUNDING TISSUE OF THE BOVINE GRAFT DEVELOPED. IT IS BELIEVED THE BOVINE GRAFT WAS EXPLANTED AND A NEW EPTFE GRAFT WAS IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME, ALTHOUGH THERE WERE SEVERAL ATTEMPTS TO CONTACT THE SURGEON. FURTHER INFORMATION IS BEING PURSUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTEGRAFT COLLAGEN VASCULAR GRAFT | VASCULAR GRAFT | LXA | ARTEGRAFT, INC. | AG UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EPTFE VASCULAR GRAFT IMPLANTED W/ATTENDANT THERAPY |