FDA Adverse Event
Injury
Summary report: N
EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM
MDR report key: 590179
·
Received April 8, 2005
Report
- Report Number
- 6000089-2005-00543
- Event Type
- Injury
- Date Received
- April 8, 2005
- Date of Event
- March 11, 2005
- Report Date
- March 11, 2005
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SAME CASE AS MANUFACTURER REPORT NUMBERS 1000089-2005-00542 AND 1000089-2005-00540. SIX MONTHS AFTER A STENTING TREATMENT PROCEDURE IN WHICH AN EXPRESS VASCULAR LD PREMOUNTED STENT WAS PLACED, ANGIOGRAM REVEALED IN-STENT RESTENOSIS. THE LESION BEING TREATED WAS AN OCCLUDED LESION IN THE RIGHT ILIAC ARTERY. ANGIOGRAM RESULTS AFTER THE STENT WAS IMPLANTED WERE 'GOOD'. THE SIX MONTH FOLLOW-UP ANGIOGRAM REVEALED AN 80% IN-STENT RESTENOTIC LESION. THE LESION WAS SUCCESSFULLY TREATED WITH BALLOON ANGIOPLASTY. PATIENT CONDITION IS REPORTED AS 'GOOD'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM | EXPRESS VASCULAR STENT LARGE DIAMETER | NIO | BOSTON SCIENTIFIC | NA | 6501494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |