FDA Adverse Event
Malfunction
Summary report: N
XPERT SELF-EXPANDING STENT SYSTEM
MDR report key: 1884879
·
Received October 15, 2010
Report
- Report Number
- 9710478-2010-00132
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- August 5, 2010
- Report Date
- August 12, 2010
- Manufacturer
- ABBOTT VASCULAR - VASCULAR SOLUTIONS
- Product Code
- FGE
- PMA / PMN Number
- K050534
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED VESSEL, THE XPERT STENT SYSTEM WAS ADVANCED THROUGH THE SHEATH TO THE TARGET LESION, HOWEVER, THE STENT DID NOT DEPLOY. THE STENT SYSTEM WAS REMOVED FROM THE PT'S ANATOMY AND ANOTHER 6/40 XPERT STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED. DURING RETURN DEVICE ANALYSIS, THE GLUING CONNECTION BETWEEN THE OUTER TUBE AND MANIFOLD WAS FOUND TO BE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XPERT SELF-EXPANDING STENT SYSTEM | FGE | ABBOTT VASCULAR - VASCULAR SOLUTIONS | NA | 65239146 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SHEATH: TERUMO 4F| GUIDE WIRE: POINTER WIRE 0.018 |