FDA Adverse Event
Malfunction
Summary report: N
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYST
MDR report key: 1052562
·
Received May 22, 2008
Report
- Report Number
- 2953144-2008-00932
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 28, 2008
- Report Date
- April 28, 2008
- Manufacturer
- ABBOTT VASCULAR REDWOOD CITY
- Product Code
- FGE
- PMA / PMN Number
- K050103
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 DEVICE PREPARATION. SYMPTOMS/AE: NA. IT WAS REPORTED THAT DURING DEVICE PREPARATION, IT WAS NOTICED THAT THE XCEED STENT WAS PREMATURELY, PARTIALLY DEPLOYED. THERE WAS NO PATIENT INVOLVEMENT. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYST | FGE | ABBOTT VASCULAR REDWOOD CITY | NA | 45112-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |