FDA Adverse Event
Injury
Summary report: N
SUPERA BILIARY STENT DELIVERY SYSTEM
MDR report key: 2598943
·
Received May 30, 2012
Report
- Report Number
- 3005325609-2012-00016
- Event Type
- Injury
- Date Received
- May 30, 2012
- Date of Event
- April 25, 2012
- Report Date
- May 3, 2012
- Manufacturer
- IDEV TECHNOLOGIES, INC.
- Product Code
- FGE
- PMA / PMN Number
- K071646
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION - THERE IS NO INDICATION OF A DEVICE MALFUNCTION. THE CAUSE OF THE EVENT IS LIKELY DUE TO THE PT'S DISEASE PROGRESSION. THE DEVICE HAS THE CE MARK FOR THE PERIPHERAL VASCULAR INDICATION IN EUROPE. THE PT HAD TWO STENTS AND BOTH HAD RESTENOSIS (REF 3005325609-2012-00015).
Description of Event or Problem · 1
THE PT WAS INCLUDED IN THE (B)(4) REGISTRY. APPROX THREE YEARS AFTER THE IMPLANT, THE PT PRESENTED WITH PAIN. A DUPLEX SONOGRAPHY SHOWED APPROX 70% STENOSIS. A BALLOON PTA WAS PERFORMED TO TREAT THE OCCLUSION WITH GOOD ANGIOGRAPHIC RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUPERA BILIARY STENT DELIVERY SYSTEM | FGE | IDEV TECHNOLOGIES, INC. | SE-05-060-120-G2 | F00238 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| R |