FDA Adverse Event
Other
Summary report: N
XCEED NITINOL SELF-EXPANDING TRASHEPATIC BILIARY STENT SYSTE
MDR report key: 838416
·
Received February 16, 2007
Report
- Report Number
- 2953144-2007-00071
- Event Type
- Other
- Date Received
- February 16, 2007
- Date of Event
- January 3, 2007
- Report Date
- January 17, 2007
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- FGE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BASED ON AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS ATTRIBUTED TO THIS INCIDENT.
Description of Event or Problem · 1
A PHYSICIAN ATTEMPTED TO DEPLOY AN XCEED STENT INTO THE LEFT SUPERFICIAL FEMORAL ARTERY. THE STENT WOULD NOT COMPLETELY DEPLOY. THE STENT WAS REMOVED AND REPLACED WITH ANOTHER 7MM XCEED STENT. THERE WERE NO REPORTS OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XCEED NITINOL SELF-EXPANDING TRASHEPATIC BILIARY STENT SYSTE | BILIARY CATHETER AND ACCESSORIES | FGE | ABBOTT VASCULAR INC. | NA | 45069-6H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |