FDA Adverse Event
Injury
Summary report: N
XACT CAROTID STENT SYSTEM
MDR report key: 1032097
·
Received April 18, 2008
Report
- Report Number
- 9616695-2008-00049
- Event Type
- Injury
- Date Received
- April 18, 2008
- Date of Event
- March 24, 2008
- Report Date
- March 25, 2008
- Manufacturer
- ABBOTT VASCULAR - VASCULAR SOLUTIONS - ABBOTT VASCULAR GALWAY
- 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 STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.
Description of Event or Problem · 1
STUDY EVENT. SYMPTOMS/AE: IN-STENT RESTENOSIS. TIME OF SYMPTOMS: APPROX ONE YR POST PROCEDURE. IT WAS REPORTED THAT APPROX ONE YR POST AN UNEVENTFUL LEFT INTERNAL CAROTID ARTERY (LICA) STENTING PROCEDURE, THE FOLLOW-UP CAROTID ANGIOGRAM IN 2008 DOCUMENTED TOTAL OCCLUSION OF THE PREVIOUSLY STENTED LEFT INTERNAL CAROTID ARTERY. THERE IS NO REPORTED TREATMENT SCHEDULED AND NO NEUROLOGICAL DEFICITS REPORTED. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XACT CAROTID STENT SYSTEM | NIM | ABBOTT VASCULAR - VASCULAR SOLUTIONS - ABBOTT VASCULAR GALWAY | NA | 40503-6G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ZIP WIRE| COOK SHEATH| EMBOSHIELD| COOK CATHETER| HEPARIN| AMPLATZ SUPER STIFF |