FDA Adverse Event
Malfunction
Summary report: N
LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM
MDR report key: 1061990
·
Received June 13, 2008
Report
- Report Number
- 2134265-2008-01690
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- May 29, 2008
- Report Date
- May 29, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- MAF
- PMA / PMN Number
- P040016
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 70% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED, NON-TORTUOUS MID THIRD OF THE RIGHT CORONARY ARTERY (RCA). WHEN THE PHYSICIAN ATTEMPTED TO PASS THE 2.50X20MM LIBERTE BARE METAL STENT OVER THE WIRE, HE NOTICED THE PROXIMAL PORTION OF THE STENT WAS 'LIGHTLY OPEN'. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PT COMPLICATIONS WERE REPORTED. PT STATUS REPORTED AS "STABLE".
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 | 11616004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |