FDA Adverse Event
Injury
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 691976
·
Received March 23, 2006
Report
- Report Number
- 3004742046-2006-00124
- Event Type
- Injury
- Date Received
- March 23, 2006
- Date of Event
- June 6, 2005
- Report Date
- February 21, 2006
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IN 2006 THE STENT FRACTURED INSIDE THE PATIENT ON 06/06/2005. IN AN EFFORT TO REMOVE THE BROKEN PIECES FROM THE ILIAC ARTERY A PERFORATION OF THE EXTERNAL ILIAC ARTERY OCCURRED RESULTING IN THE LOSS OF THE PATIENT'S LEG AT THE HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RX ACCULINK CAROTID STENT SYSTEM | CAROTID STENT SYSTEM | NIM | GUIDANT ENDOVASCULAR SOLUTIONS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention| S |