FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
MDR report key: 1221557
·
Received November 5, 2008
Report
- Report Number
- 9710478-2008-00152
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 14, 2008
- Report Date
- October 15, 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
- DC, 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 DEPLOYMENT. TIME OF MALFUNCTION: DURING UNPACKAGING. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING UNPACKAGING IT WAS NOTED THAT THE XPERT STENT WAS PARTIALLY DEPLOYED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | FGE | ABBOTT VASCULAR SWITZERLAND | NA | 546677 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |