FDA Adverse Event
Injury
Summary report: N
GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
MDR report key: 4012118
·
Received August 15, 2014
Report
- Report Number
- 3003910212-2014-00023
- Event Type
- Injury
- Date Received
- August 15, 2014
- Date of Event
- May 19, 2014
- Report Date
- October 8, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- FTM
- PMA / PMN Number
- K043056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SALEH, MEHDI. 2014 LAPAROSCOPIC SLEEVE GASTRECTOMY USING A SYNTHETIC BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL: 6 YEAR OUTCOMES. 1-47.
Description of Event or Problem · 1
THIS REPORT IS BEING SUBMITTED AS FOLLOW UP 1 TO MFR REPORT 3003910212-2014-00023 .
Description of Event or Problem · 1
GORE RECEIVED AN ARTICLE, "LAPAROSCOPIC SLEEVE GASTRECTOMY USING A SYNTHETIC STAPLE LINE REINFORCEMENT MATERIAL: 6 YEAR OUTCOMES." REVIEW OF THE ARTICLE IDENTIFIED THE USE OF GORE® SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT FROM DECEMBER 2007 UNTIL MAY 2013. DURING THIS TIME COMPLICATIONS THAT WERE OBSERVED WERE: 2 STAPLE LINE LEAKS THAT REQUIRED REOPERATION WITH INTRA-OPERATIVE BLOOD TRANSFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490456 | GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL | MESH, SURGICAL | FTM | W.L. GORE & ASSOCIATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other| R |