FDA Adverse Event
Injury
Summary report: N
ENDOLOGIX POWERLINK INFRARENAL PROXIMAL CUFF
MDR report key: 621069
·
Received July 13, 2005
Report
- Report Number
- 2031527-2005-00010
- Event Type
- Injury
- Date Received
- July 13, 2005
- Date of Event
- April 29, 2005
- Report Date
- July 1, 2005
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT TREATED IN 2005, SUCCESSFULY IMPLANTING A STENT AND PROXIMAL CUFF. PER PHYSICIAN, VISUALIZATION WAS "POOR". NO LEAKS WERE NOTED. DURING SCHEDULED FOLLOW-UP AN ANGIOGRAPHY PERFORMED AND AN ENDOLEAK WAS OBSERVED. A 28MM BALLOON WAS INFLATED TWICE IN AN ATTEMPT TO OPEN THE CUFF AND STOP THE LEAK. ON THE 2ND INFLATION, IT WAS NOT NOTICED THAT THE BALLOON WAS MOVED WITHOUT BEING FULLY DEFLATED. THE PROXIMAL CUFF WAS MOVED 10-12MM. THE PROCEDURE WAS TERMINATED. PATIENT IS CONSIDERED NON-SURGICAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOLOGIX POWERLINK INFRARENAL PROXIMAL CUFF | INFRARENAL PROXIMAL CUFF | MIH | ENDOLOGIX, INC. | 28-28-75L | W04-0597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |