FDA Adverse Event
Other
Summary report: N
POWERLINK SYSTEM
MDR report key: 722562
·
Received June 2, 2006
Report
- Report Number
- 2031527-2006-00011
- Event Type
- Other
- Date Received
- June 2, 2006
- Date of Event
- January 7, 2006
- Report Date
- June 2, 2006
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
PHYSICIAN REPORTED 30-DAY FOLLOW UP (FOR A PT IMPLANT ON 12/19/05) ON 5/5/06, PT TAKEN TO OR ON 1/7/06 TO PERFORM THROMBECTOMY OF RIGHT ILIAC. ADDITIONAL INFO HAS BEEN REQUESTED; WILL PROVIDE WHEN AVAILABLE. ADDITIONAL INFO RECEIVED ON 6/9/06: THE RIGHT GRAFT LIMB WAS THROMBOSED AND THE COVERED STENT WAS PLACED IN THE PREVIOUS GRAFT LIMB EXTENDING OUT INTO THE NATIVE VESSEL.
Description of Event or Problem · 1
PHYSICIAN REPORTED 30-DAY FOLLOW UP (FOR A PT IMPLANT IN 2005) FIVE MONTHS LATER PT TAKEN TO OR IN 2006 TO PERFORM THROMBECTOMY OF RIGHT ILIAC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | BIFURCATED INFRARENAL STENT GRAFT | MIH | ENDOLOGIX, INC. | 25-16-135BL | W05-1065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |