BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS MULTILINK HP 35X15

    MDR report key: 209257 · Received February 4, 1999

    Report

    Report Number
    MW4002373
    Event Type
    Malfunction
    Date Received
    February 4, 1999
    Date of Event
    August 12, 1998
    Report Date
    December 17, 1998
    Manufacturer
    GUIDANT CORP.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN CATHLAB FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING THE PROCESS, DOC ADVANCED THE CORONARY STENT DELIVERY SYSTEM BUT THE GUIDE CATHETER BACKED OUT OF THE OSTIUM AND "THE WIRE/STENT PLACE MEET SYSTEM WAS LOST." DOC REMOVED THE GUIDE CATHETERS STENT DELIVERY SYSTEM, AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY GUIDEWIRE. UPON REMOVAL, THE STENT WAS NOT ON THE DELIVERY SYSTEM. PERFORMED EXAM OF SHEATH, GUIDE CATHETER, AND ALL ACCESSORIES BUT STENT COULD NOT BE LOCATED THROUGH USE OF FLUOROSCOPY OR CINE MODES. DOC USED A NEW GUIDE AND STENT DELIVERY SYSTEM TO RECANNULATE THE CORONARY ARTERY DISEASE AND TWO MULTILINK CORONARY STENT WERE SUCCESSFULLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTILINK HP 35X15 Implant * MAF GUIDANT CORP. * 8063052

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR