FDA Adverse Event
Injury
Summary report: N
XACT CAROTID STENT SYSTEM
MDR report key: 1841993
·
Received September 21, 2010
Report
- Report Number
- 3004742046-2010-00432
- Event Type
- Injury
- Date Received
- September 21, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 27, 2010
- Manufacturer
- ABBOTT VASCULAR-VASCULAR SOLUTIONS
- Product Code
- NIM
- PMA / PMN Number
- P040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING STENT DEPLOYMENT IN THE RIGHT INTERNAL CAROTID ARTERY, THE STENT MOVED PROXIMALLY AND DID NOT FULLY COVER THE TARGET LESION. A SECOND STENT WAS DEPLOYED TO COVER THE DISTAL PORTION OF THE LESION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XACT CAROTID STENT SYSTEM | NIM | ABBOTT VASCULAR-VASCULAR SOLUTIONS | NA | 0011851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | LOT#00700151)| EMBOLIC PROTECTION: EMBOSHIELD NAV 6 (22438-19,| OTHER: HEPARIN |