FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
MDR report key: 1161497
·
Received September 15, 2008
Report
- Report Number
- 9710478-2008-00114
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 25, 2008
- Report Date
- August 25, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
DEVICE MALFUNCTION: PREMATURE, PARTIAL DEPLOYMENT. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING UNPACKAGING, IT WAS NOTICED THAT THE XPERT STENT WAS PREMATURELY, PARTIALLY DEPLOYED. THIS OCCURRED OUTSIDE OF THE BODY AND THERE WAS NO PT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |