FDA Adverse Event
Injury
Summary report: N
GORE® EXCLUDER® AAA ENDOPROSTHESIS
MDR report key: 4142494
·
Received October 6, 2014
Report
- Report Number
- 2953161-2014-00109
- Event Type
- Injury
- Date Received
- October 6, 2014
- Date of Event
- September 6, 2007
- Report Date
- September 17, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO LYMPH COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
ON (B)(6) 2007, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AT THE END OF THE PROCEDURE, A LYMPHORRHEA WAS IDENTIFIED AT THE ACCESS SITE. THE PHYSICIAN ELECTED TO FOLLOW UP THE PATIENT AND CONCLUDED THE PROCEDURE. ON (B)(6) 2007, A SURGICAL LIGATION WAS PERFORMED TO TREAT THE LYMPHORRHEA, WHICH WAS SUCCESSFULLY RESOLVED. THE MANUFACTURER OF THE SHEATH IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624152 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 04889205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| R | ALSO IMPLANTED ON (B)(6) 2007: PXC141000/05102040 |