FDA Adverse Event
Injury
Summary report: N
ADVANTA VXT
MDR report key: 2963565
·
Received January 2, 2013
Report
- Report Number
- 1219977-2012-00145
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- May 20, 2011
- Report Date
- November 14, 2011
- Manufacturer
- ATRIUM MEDICAL CORP.
- Product Code
- DSY
- PMA / PMN Number
- K992960
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE WALL THICKNESS OF THE EXPLANTED GRAFT IN THE AREA WHERE THE SEROMA HAD FORMED MEETS SPECIFICATION. THE REVIEW OF THE LOT HISTORY RECORD INCLUDES WALL THICKNESS MEASUREMENTS AND DEMONSTRATES THE GRAFT WALL OF THE ENTIRE LOT MEETS SPECIFICATION, THEREFORE, SEROMA FORMATION WAS NOT CAUSED BY AN OUT OF SPECIFICATION OR THIN WALLED GRAFT. THE VISUAL ANALYSIS OF THE PROVIDED SAMPLE DOES NOT REVEAL ANY POTENTIAL CAUSE OF SEROMA.
Description of Event or Problem · 1
THE GRAFT WAS IMPLANTED AS A LEFT UPPER ARM SHUNT ON (B)(6) 2010. THE PATIENT VISITED THE HOSPITAL FOR A FOLLOW-UP AND SEROMA FORMATION WAS SUSPECTED. ON (B)(6) 2011, A RE-DO PROCEDURE WAS PERFORMED AND THE GRAFT WAS EXPLANTED. THE EXPLANTED GRAFT WALL WAS THINNER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1606 | ADVANTA VXT | DSY | ATRIUM MEDICAL CORP. | 22017 | AI3607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | GRAFT REPLACED WITH AN ADVANTA 6MM GRAFT| OPERATION TO CLOSE FISTULA| PATIENT FOLLOW-UP |