FDA Adverse Event
Death
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 620096
·
Received July 8, 2005
Report
- Report Number
- 3004742046-2005-00133
- Event Type
- Death
- Date Received
- July 8, 2005
- Date of Event
- May 25, 2005
- Report Date
- June 9, 2005
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT IN 2005, THI STUDY PATIENT DIED.
Description of Event or Problem · 1
ADDITIONAL INFO RECEIVED ON 7/13/2005, STATED THAT THE DATE OF THE STENT IMPLANT WAS 5/13/2005. ADDITIONALLY, IT WAS REPORTED THAT THE PT EXPERIENCED DYSARTHRIA IN 2005. NERUOLOGIST DID NOT COMPLETE POST PROCEDURE NEURO-EXAM. HE DOES MAKE NOTE THE PT STATUS HAS NOT CHANGED POST PROCEDURE. PT UNDERWENT STENTING OF THIS VERTEBRAL ARTERY IN 2005. THE NERUOLOGIST NOTED THAT THE NIH SCORE WAS 6, BUT HAD NO WAY OF KNOWING IF IT IS SCORED THE SAME AS BASELINE. ADDITIONAL INFO PROVIDED BY THE SITE CLINICAL COORD REVEALED THAT NO STENTS WERE IMPLANTED IN THE VERTEBRAL ARTERY IN 2005, THIS PROCEDURE WAS AN ANGIOPLASTY PROCEDURE. BOTH OF THE PROCEDURES WERE PLANNED PROCEDURES.
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 | 84 YR | Death |