FDA Adverse Event
Injury
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 617205
·
Received June 24, 2005
Report
- Report Number
- 3004742046-2005-00114
- Event Type
- Injury
- Date Received
- June 24, 2005
- Date of Event
- April 20, 2005
- Report Date
- May 27, 2005
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING HOSPITALIZATION THE PT EXPERIENCED SMALL AREA OF DECREASE VISION IN THE RIGHT EYE. PROCEDURE IMPROVED AT 24 HOURS. PT REPORTS AFTER VASCULAR STENT PROCEDURE IN 2005, VA WAS BLURRY AND STATED THAT ONE MONTH AGO HAD VASCULAR SPASM AND VA WENT BLANK, LED TO STENT. BY HX HAS OCCLUSION IN OS LOSS OF CENTRAL VA IN OD AND RETINAL SPEICALIST FOUND PLAQUE IN OD. VA: OD 20/30-1, OS 20/CF 4FT. PT HAD LOSS OF VISION IN OS APPROXIMATELY 20 YEARS. HAS SCAR TISSUE ON RETINAL OS AND PROBLEM NOW IS NOT FIXABLE. PT HAS A DARK FIELD. NO ACUTE PATHOLOGY DUE TO ANGIOPLASTY, HAS LARGE SCAR OS AND THAT IS WHY PT IS NOT SEEING WELL OS.
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 | 76 YR | Hospitalization| S |