BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2884069 · Received December 21, 2012

    Report

    Report Number
    2024168-2012-08281
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. VESSEL DISSECTION OCCLUSION AND DEATH ARE LISTED AS KNOWN ADVERSE EVENTS IN THE RX TREK INSTRUCTIONS FOR USE (IFU. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIFFICULT HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) TO LEFT MAIN (LM) STENTING PROCEDURE, MULTIPLE BALLOONS WERE USED TO PRE-DILATE THE RESISTANT LONG LESION. AFTER PRE-DILATATION WITH A 2.5X20MM TREK OTW BALLOON DILATATION CATHETER, THE VESSEL BECAME OCCLUDED, POSSIBLY DUE TO A DISSECTION. ELECTROCARDIOGRAM (EKG) CHANGES WERE NOTED. OTHER BALLOON DILATATION CATHETERS WERE USED TO RE-OPEN THE VESSEL AND CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED. EVENTUALLY, FLOW WAS RESTORED, BUT CPR CONTINUED OFF AND ON. STENTING OF THE LAD WAS ATTEMPTED, BUT THE 2.5X12MM XIENCE OTW AND THE 2.75X33MM XIENCE PRIME STENT FAILED TO CROSS THE LESION AND WERE REMOVED WITHOUT ISSUE. A 3.5X12MM XIENCE RX WAS IMPLANTED IN THE LEFT MAIN WITHOUT ISSUE. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE AND RESUSCITATION WAS STOPPED, PRONOUNCING THE PATIENT DEAD ON (B)(6) 2012. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death