FDA Adverse Event
Injury
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 741320
·
Received July 12, 2006
Report
- Report Number
- 3004742046-2006-00310
- Event Type
- Injury
- Date Received
- July 12, 2006
- Date of Event
- May 24, 2006
- Report Date
- June 21, 2006
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DURING PROCESSING OF THIS COMPLAINT, QUALITY ASSURANCE ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS, FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR.
Description of Event or Problem · 1
CAPTURE STUDY EVENT. DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: STROKE, PARTIAL HEMIANOPIA. TIME OF SYMPTOMS/AE: 1-DAY POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT INTERNAL CAROTID STENT PLACEMENT AND ONE DAY POST-PROCEDURE HE SHOWED SYMPTOMS OF A STROKE (PARTIAL HEMIANOPIA). THE CONDITION WAS REPORTED AS A CONTINUING AND IMPROVED. THE PATIENT WAS DISCHARGED TO HOME ON MAY-25-2006. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
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 | 6042151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Disability | SHEATH: 6F SHEATH. OTHER: RX ACCUNET| 5.0 MM VIATRAC 14+| DILATATION CATHETER: 4.0 MM VIATRAC 14+ |