FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER ZZZ ENDOPROSTHESIS
MDR report key: 3212756
·
Received July 1, 2013
Report
- Report Number
- 2953161-2013-00096
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES IS BEING CONDUCTED.
Description of Event or Problem · 1
ON (B)(6) 2013, THE PT UNDERWENT REINTERVENTION AND THE ORIGINALLY IMPLANTED GORE EXCLUDER BIFURCATED ENDOPROSTHESES WERE RELINED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESIS. DURING THE PROCEDURE A SLIGHT TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY WAS CONSIDERED A POSSIBILITY; HOWEVER, CATHETER BASED IMAGING WAS UNABLE TO CONFIRM A TYPE II. THE PT TOLERATED THE PROCEDURE. ANEURYSM ENLARGEMENT FROM 5.5CM TO 6.7CM IN DIAMETER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297311 | GORE EXCLUDER ZZZ ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES | 030760105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| O| R | PCA201200/02988414| PCA220300/03196115 |