FDA Adverse Event
Injury
Summary report: N
XACT CAROTID STENT SYSTEM
MDR report key: 1040172
·
Received May 8, 2008
Report
- Report Number
- 9616695-2008-00069
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- October 9, 2006
- Report Date
- April 14, 2008
- Manufacturer
- ABBOTT VASCULAR GALWAY
- Product Code
- NIM
- PMA / PMN Number
- P040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE LOT HISTORY IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.
Description of Event or Problem · 1
DEVICE MALFUNCTION: NONE, SYMPTOMS/AE: IN-STENT RESTENOSIS, TIME OF SYMPTOMS/AE: APPROXIMATELY 8 MONTHS POST PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST AN UNEVENTFUL LEFT COMMON CAROTID ARTERY STENTING PROCEDURE, IT WAS DISCOVERED THAT THE STENT WAS RESTENOSED. THE RESTENOSIS WAS SUCCESSFULLY TREATED WITH A SINGLE STENT ACROSS THE COMMON CAROTID FOCAL LESION. THE PATIENT DISCHARGED TO HOME TWO DAYS LATER. ALTHOUGH REQUESTED THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XACT CAROTID STENT SYSTEM | NIM | ABBOTT VASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |