BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2624792 · Received January 7, 2010

    Report

    Report Number
    2624792
    Event Type
    Malfunction
    Date Received
    January 7, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 29, 2009
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST ATTEMPTED TO DEPLOY A STENT INTO RIGHT ILIAC ARTERY. STENT DID NOT DEPLOY AND WAS IRRETRIEVABLE. CARDIOLOGIST PROGRESS NOTE SAYS: R ILIAC ABOUT 99 PERCENT STENOSED. SELF-EXPANDABLE STENT DEPLOYED IN RIGHT ILIAC BUT I WAS UNABLE TO PULL THE CATHETER SHAFT OUT. SURGEON CONSULTED AND PATIENT TAKEN TO OPERATING ROOM TO HAVE REMOVAL OF THE DEVICE. SURGICAL NOTES INCLUDED: INCISION MADE OVER RIGHT COMMON FEMORAL ARTERY ABOVE THE DEPLOYMENT DEVICE. FEMORAL ARTERY IS DISSECTED FREE. THE ILIAC IS EXPOSED FOR ITS ALMOST ENTIRE LENGTH IN THE ABDOMEN. DEPLOYMENT DEVICE PALPATED; ILIAC CLAMPED ABOVE THIS AND THEN AT IT'S FURTHEST REACH IN THE ABDOMEN, ARTERIOTOMY PERFORMED. THE STENT AND DEPLOYMENT DEVICE ARE REMOVED FROM ABOVE AND THEN FROM BELOW UNTIL ALL FOREIGN OBJECTS HAD BEEN COMPLETELY REMOVED. CLAMPS WERE REPLACED. BECAUSE OF THE STENT PERFORMED A PARTIAL DISSECTION AND ENDARTERECTOMY, THIS IS PERFORMED, ALL DEBRIS IS REMOVED, THEN THE ARTERY IS DOUBLY OVERSEWN. FOLLOWING THE SURGERY THERE WERE EXCELLENT DOPPLER SIGNALS IN THE RIGHT FOOT. PATIENT DISCHARGED HOME ON (B)(6) 2009 AT THE SAME FUNCTIONAL LEVEL PRESENT UPON ADMISSION AND WITH GOOD PULSES I THE LOWER EXTREMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC OTW COMPLETE SE BILIARY SELF-EXPANDING FGE MEDTRONIC, INC. 001066126

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR