BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT W/DELIVERY SYSTEM

    MDR report key: 64195 · Received January 8, 1997

    Report

    Report Number
    2247023-1997-00014
    Event Type
    Death
    Date Received
    January 8, 1997
    Date of Event
    December 2, 1996
    Report Date
    January 8, 1997
    Manufacturer
    NEW JERSY PLANT
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTS TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM TO THE TARGET LESION SITE IN THE PT'S SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDIG ARTERY, THE PROTECTIVE SHEATH RETRACTED. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE SDS AND STENT AS ONE UNIT DURING WHICH THE STENT DISLODGED OFF THE BALLOON CATHETER AND EMBOLIZED IN THE ARE OF THE AORTA. A MICROSNARE WAS INTRODUCED TO RETRIEVE THE STENT. DURING RETRIEVAL ATTEMPTS, THE STENT EMBOLIZED IN THE SUBCUTANEOUS TISSUE OF THE LEFT GROIN. NO FURTHER ACTIONS WERE PERFORMED. SEVERAL HRS SUBSEQUENT, CARDIOGENIC SHOCK ENSUED AND THE PT EXPIRED. THE PHYSICIAN DID NOT CONSIDER THE DEATH RELATED TO THE ATTEMPTING STENTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON EXPANDABLE STENT W/DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF NEW JERSY PLANT NA 117331

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| R