BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS RX MULTI-LINK HP CORONARY STENT SYSTEM

    MDR report key: 209267 · Received February 4, 1999

    Report

    Report Number
    2024168-1999-00026
    Event Type
    Malfunction
    Date Received
    February 4, 1999
    Date of Event
    August 12, 1998
    Report Date
    January 5, 1999
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY/STENT PROCEDURE, A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS DONE. DURING THE PROCEDURE THE PHYSICIAN ADVANCED THE CORONARY STENT DELIVERY SYSTEM BUT THE GUIDE CATHETER BACKED OUT OF THE OSTIUM AND THE STENT/WIRE PLACEMENT WAS LOST. THE GUIDE CAHTETER, STENT DELIVERY SYSTEM AND THE GUIDE WIRE WERE REMOVED. UPON REMOVAL THE STENT WAS NOT ON THE DELIVERY SYSTEM. AN EXAMINATION WAS PERFORMED OF THE SHEATH, GUIDE CATHETER AND ALL ACCESSORIES, BUT THE STENT COULD NOT BE LOCATED. A NEW GUIDE AND STENT DELIVERY SYSTEM WERE ADVANCED TO RECANNULATE THE LEFT ANTERIOR DESCENDING AND TWO STENTS WERE SUCCESSFULLY DEPLOYED. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX MULTI-LINK HP CORONARY STENT SYSTEM Implant CORONARY STENT SYSTEM MAF GUIDANT VASCULAR INTERVENTION NA 8063052

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR