BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 469679 · Received July 2, 2003

    Report

    Report Number
    9616290-2003-00008
    Event Type
    Death
    Date Received
    July 2, 2003
    Date of Event
    May 1, 2003
    Report Date
    June 26, 2003
    Manufacturer
    JOMED GMBH
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY USING A CUTTING BALLOON AND SUFFERED A LACERATION OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING AN ATTEMPTED RESUSCITATION A JOSTENT WAS USED. THE OSTIUM OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS HEAVILY CALCIFIED AND JOSTENT WOULD NOT PASS THROUGH; THEREFORE WAS NOT DEPLOYED. PATIENT REQUIRED STERNOTOMY DIRECT COMPRESSION OF THE LACERATED LAD. A VIABLE RHYTHM COULD NOT BE RE-ESTABLISHED AND PATIENT DIED IN THE CATH LAB. PHYSICIAN HAS NOTED THAT THE COMPLICATION WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT MAF JOMED GMBH 010CG16UA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death