BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1575122 · Received January 7, 2010

    Report

    Report Number
    2031527-2009-00173
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    October 30, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 34-34-80L, LOT NO. W09-0749-006, EXPIRATION DATE: 04/01/2012. REVIEW OF WORK ORDERS/LOT RECORDS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE TECHNICIAN INADVERTENTLY OVERINFLATED THE BALLOON, PERFORATING THE AORTIC NECK.

    Description of Event or Problem · 1

    IN 2009, PATIENT IMPLANT OF A 28-16-120BL BIFURCATED DEVICE AND A 34-34-100RLE SUPRARENAL PROXIMAL EXTENSION. DURING POST-DILATATION BALLOONING, THE TECH INADVERTENTLY OVER INFLATED THE BALLOON, WHICH PERFORATED THE AORTIC NECK. A 34-34-80LE INFRARENAL PROXIMAL EXTENSION AND A PALMAZ STENT WERE PLACED TO EXCLUDE THE PERFORATION. NO ENDOLEAK NOTED AT THE END OF THE CASE. FOLLOW UP IMAGES REVEALED A PSEUDOANEURYSM DUE TO THE NECK PERFORATION, WHICH WAS LEAKING INTO THE PRIMARY ANEURYSM. TWO MONTHS LATER, AN ATTEMPT TO TREAT THE PSEUDOANEURYSM WAS MADE WITH AN ADDITIONAL 34-34-80L, HOWEVER, UNABLE TO GET GOOD SEAL. THE DECISION WAS MADE TO CONVERT THE PATIENT TO OPEN REPAIR AND EXPLANT ALL DEVICES. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 34-34-100RLE W09-1062-016

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention