FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM
MDR report key: 1022103
·
Received March 25, 2008
Report
- Report Number
- 9710478-2008-00033
- Event Type
- Malfunction
- Date Received
- March 25, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 12, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE.
Description of Event or Problem · 1
DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF DEVICE MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING UNPACKAGING THE XPERT STENT WAS FOUND PREMATURELY, PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND 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 BILLIARY STENT SYSTEM | FGE | ABBOTT VASCULAR SWITZERLAND | NA | 468108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |