BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1081670 · Received July 24, 2008

    Report

    Report Number
    2024168-2008-00601
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - STENT DISLODGEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, EXTREME TORTUOSITY OR LESION RESISTANCE, INTERACTION OF STENT WITH ACCESSORY DEVICES, CROSSING PREVIOUSLY DEPLOYED STENT, EXCESSIVE FORCE TO RETRACT UNDEPLOYED STENT INTO GUIDING CATHETER OR IMPROPER/INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE. THE LESION WAS HEAVILY CALCIFIED, INVOLVING OTHER DEVICES AND A DOTTERING TECHNIQUE WAS USED. THESE FACTORS MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT. THE ROOT CAUSE IS UNKNOWN. THERE IS NO INDICATION OF A QUALITY ISSUE. THE PATIENT EFFECT OF UNRETRIEVED NON-RESORBABLE MATERIALS IN THE BODY IS A KNOWN LIKELY PATIENT EFFECT ASSOCIATED WITH STENT DISLODGEMENT.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: DISLODGED STENT REMAINS IN PATIENT. REPORTING RATIONALE: DISLODGED STENT. IT WAS REPORTED THAT THIS CASE WAS A HEAVILY CALCIFIED RCA. AFTER THE USE OF MULTIPLE GUIDE WIRES, MULTIPLE DILATATION BALLOONS AND MULTIPLE STENTS WHICH WERE PLACED SUCCESSFULLY, AN ATTEMPT WAS MADE TO PLACE THIS LAST STENT, A MINI VISION, PROXIMALLY. DURING THIS ATTEMPT, USING A DOTTERING TECHNIQUE, THE STENT BECAME DISLODGED FROM THE BALLOON AND TRAVELED DOWN TO A SMALL SIDE BRANCH BELOW THE RENALS, INTO THE AORTA, WHERE IT REMAINS. THE PATIENT WAS SCHEDULED FOR CABG LATER TODAY BECAUSE OF UNSATISFACTORY RESULTS OF THE PROCEDURE, NOT BECAUSE OF THE DISLODGED STENT, WHICH WILL REMAIN IN THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8032731

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability