FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 756526
·
Received August 29, 2006
Report
- Report Number
- 2031527-2006-00026
- Event Type
- Other
- Date Received
- August 29, 2006
- Date of Event
- August 23, 2006
- Report Date
- August 29, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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
DURING IMPLANT PROCEDURE, THE LIMB OF THE BIFURCATED STENT GRAFT DEVICE WAS DAMAGED INSIDE THE PATIENT, CAUSING OCCLUSION, WHICH REQUIRED A FEM-FEM BYPASS PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-140BL | W06-0661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | POWERLINK LIMB EXTENSION (16-16-88L, W06-0351 )| POWERLINK INFRARENAL CUFF (34-34-80L, W06-0723)| (16-16-55L, W05-440), (20-20-55L, W05-0439). |