BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1902029 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02440
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. ALTHOUGH THE ANATOMICAL CONDITIONS WERE NOT REPORTED, FAILURE TO ADVANCE IS NOT OFTEN ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, IT WAS NOTED THAT FURTHER BALLOON DILATATIONS WERE DONE AFTER THE FIRST MINI VISION STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION, WHICH SUGGESTS THE LESION WAS DIFFICULT. ADDITIONALLY, RE-INSERTION OF THE MINI VISION SDS AND/OR INTERACTION WITH THE ANATOMY LIKELY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. IT SHOULD BE NOTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU) IT STATES: "AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. 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." TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE, A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IN THIS CASE, THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.25 X 12 MINI VISION FAILED TO CROSS AND WAS REMOVED. THE 2.25 X 8 MINI VISION WAS ATTEMPTED NEXT, BUT ALSO COULD NOT CROSS. IT WAS REMOVED AND MORE BALLOONING WAS DONE. IT WAS THEN ATTEMPTED A SECOND TIME, AND AGAIN FAILED TO CROSS. THE STENT DISLODGED DURING THE REMOVAL ATTEMPT JUST PRIOR TO BEING PULLED THROUGH THE GUIDING CATHETER. NO RESISTANCE WITH THE GUIDING CATHETER WAS NOTED. AN UNSPECIFIED 2.0 X 8 BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT. THE PATIENT HAS BEEN DISCHARGED TO HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050731

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention