FDA Adverse Event
Injury
Summary report: N
SILVERHAWK® PLAQUE EXCISION SYSTEM
MDR report key: 2063662
·
Received April 20, 2011
Report
- Report Number
- 2183870-2011-00071
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- August 7, 2010
- Report Date
- March 21, 2011
- Manufacturer
- EV3 INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
THIS PROCEDURE IS PART OF THE DEFINITIVE LE TRIAL THE ORIGINAL PROCEDURE WAS PERFORMED WITH A SILVERHAWK DEVICE ON (B)(6), 2009. THE PATIENT WAS HOSPITALIZED ON FROM (B)(6), 2010 THROUGH (B)(6), 2010 AND DURING THAT TIME, THE SUBJECT WAS NOTED TO HAVE EVIDENCE OF LOWER LIMB ISCHEMIA IN THE RIGHT FOOT AND GANGRENE OF THE RIGHT GREAT TOE. ON (B)(6), 2010, THE SUBJECT UNDERWENT BELOW THE KNEE AMPUTATION AND WAS TRANSFERRED TO THE RECOVERY ROOM IN SATISFACTORY CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILVERHAWK® PLAQUE EXCISION SYSTEM | CATHETER, PERIPHERAL, ATHERECTOMY | MCW | EV3 INC. | P4055 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |