FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 751834
·
Received August 16, 2006
Report
- Report Number
- 2031527-2006-00023
- Event Type
- Other
- Date Received
- August 16, 2006
- Date of Event
- June 29, 2006
- Report Date
- August 16, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RETURNED DEVICE EVALUATED; NO ISSUES RELATED TO EVENT. LOT RECORDS REVIEWED WITH NO ANOMALIES.
Description of Event or Problem · 1
IN A REPORT FROM THE PHYSICIAN DATED 8/14/06 (PROCEDURE WAS 2006), IT WAS INDICATED THAT AFTER A SUCCESSFUL IMPLANT PROCEDURE (BIFURCATED AND CUFF STENT GRAFTS) AND DURING RECOVERY, THE PATIENT DEVELOPED RIGHT LEG ISCHEMIA REQUIRING URGENT SURGICAL INTERVENTION. THROMBECTOMY, ANGIOPLASTY AND STENTING OF THE NATIVE RIGHT ILIAC WAS PERFORMED WITH EVENT RESOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | BIFURCATED INFRARENAL STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-140BL | W06-0391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | INFRARENAL CUFF MODE 34-34-80L (LOT W06-01213) |