BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1895859 · Received November 10, 2010

    Report

    Report Number
    3005075853-2010-06419
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. ALTHOUGH, NO OPENING ISSUES WERE NOTED DURING TESTING, AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 11TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER FIRING THE INSTRUMENT, THE CLIP WAS CLOSED OVER THE VESSEL BUT THE INSTRUMENT DID NOT OPEN SO THE SURGEON HAD TO TEAR THE VESSEL. BLEEDING OCCURRED FROM THE VESSEL. THE SURGEON STOPPED THE BLEEDING AND TOOK ANOTHER DEVICE TO CONTINUE. AFTER THE SURGERY THE SURGEON TOOK THE INSTRUMENT AND TRIED TO FIND OUT WHAT WAS WRONG. THE INSTRUMENT WOULD ONLY OPEN WITH FORCE BUT THEN IT WORKED WELL. NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST XIENCE V STENT IMPLANTATION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA), PER INTRAVASCULAR ULTRASOUND (IVUS), THE XIENCE V STENT WAS NOTED TO BE POORLY APPOSED TO THE VESSEL WALL WITH APPROXIMATELY 1MM ANEURYSMS ON BOTH EDGES OF THE STENT AND 30-40% IN-STENT RESTENOSIS. IVUS WAS NOT DONE DURING INITIAL STENT IMPLANTATION, SO IT IS UNKNOWN IF THE STENT PROPERLY APPOSED THE WALL AT THAT TIME. A VOYAGER NC BALLOON WAS UNSUCCESSFULLY TAKEN TO THE STENT IN AN ATTEMPT TO BETTER APPOSE THE STENT TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1