FDA Adverse Event
Malfunction
Summary report: N
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
MDR report key: 1081513
·
Received July 25, 2008
Report
- Report Number
- 2134265-2008-02090
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 11, 2008
- Report Date
- June 27, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- MAF
- PMA / PMN Number
- P040016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE PHYSICIAN ATTEMPTED TO ADVANCE A 5.0X20MM LIBERTE' STENT TO A LESION IN THE OBTUSE MARGINAL AND CIRCUMFLEX (CX) ARTERIES. THE PHYSICIAN INTENDED TO PLACE THE STENT USING A CRUSH TECHNIQUE, "HOWEVER THE STENT STRUT IS BROKEN WHILE CROSSING THE LESION" IN THE TORTUOUS CX. UPON RECEIPT OF THE DEVICE, DURING PRELIMINARY ANALYSIS, IT WAS NOTED THAT THE SHAFT WAS BROKEN AND THERE WAS NO DAMAGE TO THE STENT. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM | MAF STENT, CORONARY | MAF | BOSTON SCIENTIFIC | NA | 11447049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |