FDA Adverse Event
Death
Summary report: N
RX ACCULINK CAROTID STENT SYSTEM
MDR report key: 652371
·
Received November 23, 2005
Report
- Report Number
- 3004742046-2005-00405
- Event Type
- Death
- Date Received
- November 23, 2005
- Date of Event
- September 28, 2005
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- NIM
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD THE FIRST CAROTID STENT PROCEDURE ON THE RIGHT SIDE (ONE STENT) IN 2005 ENROLLED AS A PT. THE PT RETURNED TO HAVE THE LEFT CAROTID ARTERY STENTED ABOUT TWO WEEKS LATER ON THE LEFT SIDE (THREE STENTS - ONE IN INTERNAL AND TWO IN EXTERNAL ARTERY) ENROLLED AS A PT. THE PT RETURNED TO THE HOSPITAL A WEEK LATER WITH SEIZURE AND STROKE LIKE SYMPTOMS. A WEEK LATER THE PT WAS CONFIRMED TO HAVE HAD A STROKE. FOUR DAYS LATER, THE PT DIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELL ON THE BACK OF HIS HEAD AND EXPERIENCED SEIZURES ON 10/21/2005. A HEAD CT SCAN ON 10/26/2005 REVEALED A RIGHT FRONTAL STROKE.
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 | 72 YR | Death| H| S |