BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 510497 · Received January 12, 2004

    Report

    Report Number
    9616290-2004-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2004
    Date of Event
    December 22, 2003
    Report Date
    December 23, 2003
    Manufacturer
    ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF THE STENT COMING OFF THE STENT DELIVERY SYSTEM. THE PT WAS UNDERGOING AN INTERVENTIONAL PROCEDURE OF THE PROXIMAL CIRCUMFLEX CORONARY ARTERY, WHICH WAS 90% STENOSED. A 2.5 X 8MM DRUG ELUTING STENT WAS PLACED IN THE PROXIMAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT A "PERFORATION" OF THE VESSEL DISTAL TO THE STENT OCCURRED. THE MD ATTEMPTED TO PLACE A CORONARY STENT GRAFT TO SEAL THE "PERFORATION"; HOWEVER, THE STENT WOULD NOT CROSS THROUGH THE PREVIOUSLY PLACED STENT. IN THE ATTEMPT TO REMOVE THE STENT, THE MD NOTED THAT THE STENT CAME OFF THE STENT DELIVERY SYSTEM AND WAS LODGED PROXIMAL TO THE DRUG ELUTING STENT. IT WAS REPORTED THAT THE PT COMPLAINED OF CHEST PAIN, WHICH WAS RATED 8 OUT OF 10 (10 BEING THE MOST SEVERE). THE MD MEDICATED THE PT WITH 200MCG NO NITROGLYCERINE INTRACORONARY. THE PT WAS NOT STARTED ON ANY MAINTENANCE INTRAVENOUS DRIPS. THE PT'S PAIN RESOLVED. A 3.0 X 13MM BALLOON WAS ADVANCED THROUGH AND INFLATED UP TO 18 ATMOSPHERES TO DEPLOY THE STENT IN THE OSTIAL/PROXIMAL AREA OF THE CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE PT'S HEART RATE WAS 75-79, MEAN ARTERIAL BLOOD PRESSURE WAS 101, RESPIRATORY RATE 14-18 AND THE OXYGEN SATURATION VIA PULSE OXIMETRY WAS 95-97%. THE PT WAS ON OXYGEN THERAPY AT 3L/MINUTE AS STANDARD CARE. THE PERFORATION WAS NOT TREATED. THE PT WAS TRANSFERRED TO THE ICU FOR MONITORING. THE PT WAS DISCHARGED IN 12/2003. THEN RETURNED TWO DAYS LATER FOR A FOLLOW-UP EXAM AND AN ECHOCARDIOGRAM. IT WAS REPORTED THAT THE PT IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT MAF ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND NA 26530WK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other