BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS RX MULTI-LINK CORONARY STENT SYSTEM

    MDR report key: 173358 · Received June 18, 1998

    Report

    Report Number
    2024168-1998-00261
    Event Type
    Injury
    Date Received
    June 18, 1998
    Date of Event
    May 18, 1998
    Report Date
    May 19, 1998
    Manufacturer
    GUIDANT ACS/DVI
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SEPARATED STENT AND C-FLEX WERE STILL ON THE SNARE AND GUIDEWIRE. THE STENT WAS SEVERELY TWISTED. THE C-FLEX WAS TORN AND SEPARATED. THE FACE OF THE REMAINING C-FLEX WAS JAGGED. THE SHRINK TUBING AND C-FLEX JUNCTION WERE INTACT. THE GUIDING CATHETER WAS NOT RETURNED. QUALITY ENGINEERING CONCLUDED THAT ALTHOUGH THE GUIDING CATHETER WAS NOT RETURNED FOR ANALYSIS, INCIDENT INFO INDICATES THE FIRST GUIDING CATHETER'S INNER DIAMETER WAS TOO SMALL, THUS THE DELIVERY SYSTEM MET RESISTANCE IN THE GUIDING CATHETER. THERE IS NO INDICATION THAT THE STENT WAS LOOSE ON THE DELIVERY SYSTEM DURING PREPARATION. THE PHYSICIAN'S ACTION OF RETRACTING THE STENT DELIVERY SYSTEM, WITH THE UNDEPLOYED STENT, INTO THE GUIDING CATHETER LIKELY LOOSENED THE STENT ON THE BALLOON, FACILITATING SEPARATION. PT CALCIUM MAY HAVE ALSO BEEN A VARIABLE TO RESISTANCE AND LOOSENING OF THE STENT. QUALITY ENGINEERING HAS DETERMINED THAT NO CORRECTIVE ACTION WILL BE IMPLEMENTED AS THE MATTER DOES NOT APPEAR TO BE RELATED TO STENT DELIVERY SYSTEM QUALITY. AS PART OF QUALITY PROCESS, ALL STENT DELIVERY SYSTEMS ARE INSPECTED ON-LINE TO ENSURE THAT EACH STENT IS SECURELY MOUNTED TO ITS BALLOON. THE DEVICE MFG RECORDS FOR THIS PRODUCT LOT WERE REVIEWED AND NO NON-CONFORMITIES WERE FOUND. THIS MDR IS CONSIDERED CLOSED BY THE QUALITY ASSURANCE DEPARTMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY/STENT PROCEDURE RESISTANCE WAS MET WHILE ADVANCING THE STENT DELIVERY SYSTEM THROUGH A GUIDING CATHETER WITH A SMALLER THAN RECOMMENDED INSIDE DIAMETER.THE STENT DELIVERY SYSTEM WAS ADVANCED FURTHER AGAINST RESISTANCE, ALSO CONTRARY TO INSTRUCTIONS FOR USE. THE DELIVERY SYSTEM WAS THEN REMOVED INTO THE GUIDING CATHETER. UPON INSPECTION IT WAS REVEALED THAT THE STENT HAD SEPARATED FROM THE DELIVERY SYSTEM. THE STENT WAS RETRIEVED WITH A SNARE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A CHANGE IN CONCOMITANT EQUIPMENT, ADDITIONAL LESION PREPARATION AND PLACEMENT OF ANOTHER COMPANY'S STENT. REPORTEDLY NO PT INJURY WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX MULTI-LINK CORONARY STENT SYSTEM Implant CORONARY STENT SYSTEM MAF GUIDANT ACS/DVI NA 8041055

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention