FDA Adverse Event
Malfunction
Summary report: N
JOHNSON & JOHNSON GENESIS STENT 6X24X80MM
MDR report key: 2192839
·
Received July 26, 2007
Report
- Report Number
- 2192839
- Event Type
- Malfunction
- Date Received
- July 26, 2007
- Date of Event
- July 10, 2007
- Report Date
- July 25, 2007
- Manufacturer
- CORDIS EUROPA SYSTEM
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT IN LAB FOR PTA/STENT OF A R SUBCLAVIAN VEIN POST ANGIOPLASTY. ATTEMPT AT STENT PLACEMENT UNSUCCESSFUL. UPON REMOVAL OF STENT AND DELIVERY SYSTEM, STENT WAS DISPLACED FROM BALLOON DELIVERY SYSTEM AT REMOVAL TIME. UPON RECOGNITION, MULTIPLE ATTEMPTS WERE MADE FO RETRIEVAL. STENT WAS THEN SAFELY DEPLOYED IN R ILIAC VEIN. NO APPARENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOHNSON & JOHNSON GENESIS STENT 6X24X80MM | PALMAZ GENESIS ENDOVASCULAR STENT | FGE | CORDIS EUROPA SYSTEM | .035 DELIVERY SYS | R0107295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | ST. JUDE MEDICAL MAXIMUM HEMOSTASIS INTRODUCERS| X 2, LOT# 2003215 |