FDA Adverse Event
Injury
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 793406
·
Received December 5, 2006
Report
- Report Number
- 3004742046-2006-00508
- Event Type
- Injury
- Date Received
- December 5, 2006
- Date of Event
- October 6, 2006
- Report Date
- November 16, 2006
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- PMA / PMN Number
- P040012
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
B5: CAPTURE 2 STUDY EVENT.
Description of Event or Problem · 1
DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: DURING HOSPITALIZATION. SYMPTOMS/AE: STROKE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED AFTER A RIGHT CEREBRAL HEMISPHERIC CVA (WITHIN PREVIOUS 7-DAYS). THE PROCEDURE DATE WAS 2006. APPROXIMATELY 36 HOURS AFTER THE LIC-CAS, THE PATIENT HAD A PROGRESSION OF THE PREVIOUS CVA IN THE AREA SERVED BY RIC ARTERY. THERE WAS NO REPORTED CHANGE IN FUNCTION OF AREA SERVED BY THE LIC ARTERY. THE TREATMENT WAS NOTED AS PHYSICAL THERAPY, OCCUPATIONAL THERAPY, AND SPEECH THERAPY, AND THE CONTINUING CONDITION WAS NOTED AS CHRONIC. THE PATIENT WAS DISCHARGED TO A REHABILITATION FACILITY/SKILLED NURSING HOME ON 8 DAYS LATER. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RX ACCULINK CAROTID STENT SYSTEM | NIM | NIM | GUIDANT ENDOVASCULAR SOLUTIONS | NA | 6080251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| S | OTHER: RX ACCUNET. |