FDA Adverse Event
Malfunction
Summary report: N
XENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1840653
·
Received September 17, 2010
Report
- Report Number
- 2024168-2010-01947
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 26, 2010
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED AND THE 3.5 X 18 XIENCE V WAS ADVANCED. DURING THE CROSS ATTEMPT, RESISTANCE WAS FELT AND AS THE DEVICE WAS PULLED BACK, THE PROXIMAL SHAFT BROKE (SEPARATED). THERE WERE NO REPORTED PT EFFECTS. NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM | NIQ | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 0040741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | DILATATION CATHETER: 2.5 X 12 MM SPINTER| INFLATION: MEDTRONIC| GUIDE WIRE: BMW| GUIDE CATH: CORDIS |