FDA Adverse Event
Injury
Summary report: N
POWERLINK SYSTEM
MDR report key: 2069451
·
Received April 26, 2011
Report
- Report Number
- 2031527-2011-00024
- Event Type
- Injury
- Date Received
- April 26, 2011
- Date of Event
- March 28, 2011
- Report Date
- June 23, 2011
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT IS UNKNOWN IF THE PATIENT ANATOMY MET THE CRITERIA FOR INDICATIONS FOR USE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE. NO CONCLUSION CAN BE DRAWN.
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Additional Manufacturer Narrative · 1
MODEL READS: 28-28-95L; SHOULD READ: 22-25-75L. LOT READS: W10-1946-001; SHOULD READ: W10-1262-014.
Description of Event or Problem · 1
PATIENT IMPLANT ON (B)(6) 2010 OF A (B)(4) BIFURCATED DEVICE, A 25MM AORTIC EXTENSION, AND A 20 MM LIMB EXTENSION. A (B)(6) 2011 FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH AORTIC STENT WHICH CORRECTED THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL PROXIMAL EXTENSION STENT GRAFT | MIH | ENDOLOGIX, INC. | 25-25-75L | W10-1262-014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |