BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 802874 · Received January 3, 2007

    Report

    Report Number
    2024168-2007-00002
    Event Type
    Injury
    Date Received
    January 3, 2007
    Date of Event
    December 4, 2006
    Report Date
    December 4, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MAF
    PMA / PMN Number
    Po20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, PRODUCT PERFORMANCE GROUP ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR. RESULTS CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT WAS REPORTED THAT THE SDS WOULD NOT CROSS THE LESION AND WHEN THE SDS WAS BEING RETRACTED INTO THE GUIDING CATHETER, THE STENT DISLODGED. THE INSTRUCTIONS FOR USE STATES THAT: "AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER." THE SECOND RX VISION INDICATED IN THE EVENT DESCRIPTION AND IN THE CONCOMITANT MEDICAL PRODUCTS IS BEING REPORTED UNDER ANOTHER MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: REMOVAL OF DISLODGED STENT FROM PATIENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LAD. THREE ATTEMPTS WERE MADE WITH THE FIRST VISION (LOT 6091231) TO CROSS, BUT IT WAS UNSUCCESSFUL EVEN AFTER THREE ADDITIONAL PRE-DILATIONS. AS THE VISION WAS BEING RETRACTED INTO THE GUIDING CATHETER, THE STENT DISLODGED. ANOTHER COMPANY'S BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT. A NEW VISION (LOT 6092531) WAS REMOVED FROM THE PACKAGE, BUT WHEN THE PROTECTIVE SHEATH WAS REMOVED, THE STENT DISLODGED ON THE STYLET WIRE. THE PROCEDURE WAS COMPLETED USING TWO OF ANOTHER COMPANY'S STENTS. THERE WERE NO PATIENT EFFECTS REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF GUIDANT VASCULAR INTERVENTION NA 6091231

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention POWERSAIL X 2 STENT: 3.0 X 12 MM RX VISION| 3.0 X 08MM RX VISION, DRIVER STENT X 2| DILITATION CATHETER: VOYAGER