FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING TRANSHEPATIC BILLIARY STENT SYSTEM
MDR report key: 1052255
·
Received May 23, 2008
Report
- Report Number
- 9710478-2008-00057
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- May 2, 2008
- Report Date
- May 2, 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF DEVICE MALFUNCTION: DURING DEVICE UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE UNPACKAGING, IT WAS NOTICED THAT THE XPERT STENT WAS PREMATURELY, PARTIALLY DEPLOYED. 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 | 457570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |