FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 3338792
·
Received October 23, 2006
Report
- Report Number
- 2031527-2006-00041
- Event Type
- Other
- Date Received
- October 23, 2006
- Date of Event
- September 2, 2006
- Report Date
- October 23, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
AFTER SUCCESSFUL IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL CUFF, PATIENT'S LEFT FOOT WAS PALE WITH NO PALPABLE PULSES OR DOPPLER SIGNALS. UPON RE-EXPLORATION OF THE FEMORAL ARTERY, A LARGE PLAQUE WAS FOUND AND AN ENDARTERECTOMY PERFORMED; ALSO APPROX TWO INCHES OF THE FEMORAL ARTERY WAS REPLACED WITH PTFE. THE VESSEL WAS CLOSED WITH BOVINE PATCHES. FLOW WAS RE-ESTABLISHED AND PATIENT'S FOOT WAS PINK WITH GOOD PULSES. PATIENT IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | SUPRARENAL CUFF STENT GRAFT | MIH | ENDOLOGIX, INC. | 34-34-100RL | W06-0212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | EXP: 03/01/2009, MFR DATE: 03/06| MODEL # 28-16-155BL, LOT # W06-0131| INFRARENAL BIFURCATED STENT GRAFT |