BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1932123 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02798
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DILATATION CATHETER: RX VOYAGER; GUIDE WIRE: WHISPER; GUIDE CATH: (B)(6). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE IFU STATES, IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREDILATATION WAS PERFORMED WITH AN RX VOYAGER. AFTER DEPLOYMENT OF THE MULTI-LINK MINI VISION WAS PERFORMED, A DISSECTION WAS NOTED, WHICH WAS TREATED WITH ANOTHER MINI VISION STENT. NO ADDITIONAL PATIENT EFFECTS WERE NOTED. 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 CORONARY STENT SYSTEM MAF AV-CLONMEL 0010841

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CONCOMITANT MEDICAL DEVICES