FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
MDR report key: 1022796
·
Received March 28, 2008
Report
- Report Number
- 9710478-2008-00038
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- January 22, 2008
- Report Date
- March 6, 2008
- Manufacturer
- ABBOTT VASCULAR SWITZERLAND
- Product Code
- FGE
- PMA / PMN Number
- K050534
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: PARTIALLY DEPLOYED STENT. TIME OF MALFUNCTION: DURING UNPACKING. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT WHILE TAKING THE DEVICE OUT OF THE PACKAGE, THE XPERT STENT WAS FOUND PREMATURELY PARTIALLY DEPLOYED. REPORTEDLY, THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | FGE | ABBOTT VASCULAR SWITZERLAND | NA | 447666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |