FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 809382
·
Received January 24, 2007
Report
- Report Number
- 2031527-2007-00003
- Event Type
- Other
- Date Received
- January 24, 2007
- Date of Event
- January 16, 2007
- Report Date
- January 24, 2007
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: 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, THE PT WAS SENT TO RECOVERY. APPROXIMATELY TWO HOURS POST IMPLANT, THE PT HAD LOST PULSE IN LEFT LEG. THE LIMB OF THE STENT GRAFT HAD KINKED/THROMBOSED. THE PATIENT WAS BROUGHT BACK TO THE O.R. WHERE THE PHYSICIAN PERFORMED AN EMBOLECTOMY OF THE LEFT ILIAC. THE LIMB OF THE STENT GRAFT WAS BALLOONED, HOWEVER, DUE TO THE PT'S ANATOMY, WOULD NOT STAY OPENED. THE PHYSICIAN DECIDED TO PLACE A COMPETITOR DEVICE INSIDE THE ENDOLOGIX DEVICE TO KEEP IT OPEN. PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-140BL | W06-1199R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |