FDA Adverse Event
Death
Summary report: N
POWERLINK SYSTEM
MDR report key: 2179672
·
Received July 27, 2011
Report
- Report Number
- 2031527-2011-00048
- Event Type
- Death
- Date Received
- July 27, 2011
- Date of Event
- June 29, 2011
- Report Date
- June 29, 2011
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
PATIENT PRESENTED WITH CALCIFIED EXTERNAL ILIAC ARTERIES WITH PREVIOUSLY IMPLANTED BARE METAL STENTS. IMPLANT OF BIFURCATED DEVICE (REF MFR REPORT #2031527-2011-00042) AND AN AORTIC EXTENSION (REF MFR REPORT #2031527-2011-00048) WAS SUCCESSFUL. PATIENT WAS TRANSFERRED TO RECOVERY AFTER COMPLETING THE PROCEDURE. THE NEXT MORNING PATIENT WAS SHOWING SIGNS OF PARAPLEGIA FROM T2 DOWN. IT WAS REPORTED PATIENT DIED ON (B)(6) 2011 OF MULTI-ORGAN FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | SUPRARENAL PROXIMAL EXTENSION STENT GRAFT | MIH | ENDOLOGIX, INC. | 34-34-120RLE | W11-1845-001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |