FDA Adverse Event
Injury
Summary report: N
SILVERHAWK® PLAQUE EXCISION SYSTEM
MDR report key: 1960906
·
Received January 14, 2011
Report
- Report Number
- 2183870-2011-00003
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- October 29, 2010
- Report Date
- December 23, 2010
- Manufacturer
- EV3 INC. PLYMOUTH, MN
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 THE REPORTED EVENT.
Description of Event or Problem · 1
THE PROCEDURE IS PART OF THE DEFINITIVE LE TRIAL: THE PATIENT EXPERIENCED A LIKELY DISTAL EMBOLIZATION EVENT POST ATHERECTOMY. THE PERONEAL ARTERY OCCLUDED IN THE MID SEGMENT, HOWEVER, DID NOT REQUIRE TREATMENT AS THE ANTERIOR TIBIAL ARTERY PROVIDED ADEQUATE FLOW TO THE FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERHAWK® PLAQUE EXCISION SYSTEM | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | EV3 INC. PLYMOUTH, MN | P4056 | 8995941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other |