FDA Adverse Event
Other
Summary report: N
SILVERHAWK LX-M PLAQUE EXCISION SYSTEM
MDR report key: 1939518
·
Received December 14, 2010
Report
- Report Number
- 2183870-2010-00200
- Event Type
- Other
- Date Received
- December 14, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 15, 2010
- Manufacturer
- EV3 INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.
Description of Event or Problem · 1
DURING A PROCEDURE ON THE RIGHT SFA, THE PHYSICIAN WAS ADVANCING THE SILVERHAWK LX-M OVER THE WIRE THROUGH ANOTHER STENT. IT WAS DIFFICULT TO ADVANCE AND ACTIVATE THE CUTTER. THE PHYSICIAN REMOVED THE DEVICE. NO INJURY TO THE PT REPORTED. EXAMINATION OF THE RETURNED SILVERHAWK DEVICE EXHIBITED A COILED SECTION OF THE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERHAWK LX-M PLAQUE EXCISION SYSTEM | MCW | EV3 INC. | P4055 | 9013990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | VIABAHN STENT, PLATINUM| PLUS WIRE |