FDA Adverse Event
Injury
Summary report: N
XACT CAROTID STENT SYSTEM
MDR report key: 1063445
·
Received June 20, 2008
Report
- Report Number
- 9616695-2008-00087
- Event Type
- Injury
- Date Received
- June 20, 2008
- Date of Event
- May 20, 2008
- Report Date
- May 28, 2008
- Manufacturer
- ABBOTT VASCULAR - VASCULAR SOLUTIONS
- Product Code
- NIM
- PMA / PMN Number
- P040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO.
Description of Event or Problem · 1
DEVICE MALFUNCTION: NONE. AE/SYMPTOMS: CONFUSION. TIME OF AE/SYMPTOMS: ONE DAY POST PROCEDURE. IT WAS REPORTED THAT ONE DAY POST A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, THE PT BECAME CONFUSED. THE PT WAS GIVEN AN EXTRA PLAVIX 150MG DOSAGE AND SENT FOR A CT SCAN OF THE HEAD WHICH WAS UNREMARKABLE . REPORTEDLY, IN THE NEXT DAY, THE CONFUSION WAS NO LONGER PRESENT. A REPEAT CT SCAN OF THE BRAIN WAS UNREMARKABLE. THE PT WAS DISCHARGED TO HOME IN THE NEXT DAY. NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XACT CAROTID STENT SYSTEM | NIM | ABBOTT VASCULAR - VASCULAR SOLUTIONS | NA | 32019-6G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | OTHER: BIVALIRUDIN| EPD: EMBOSHIELD |