BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 3901072 · Received June 30, 2014

    Report

    Report Number
    2024168-2014-04193
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. PRODUCTS: ASPIRIN, ANGIOMAX, PLAVIX, REOPRO (ABCIXIMAB). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE STENT REMAINS IN THE ANATOMY. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE MULTI-LINK MINI VISION CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH CORONARY STENTING. 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 ON (B)(6) 2014, THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A TARGET LESION IN THE PROXIMAL 1ST DIAGONAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE 2.0 X 23 MM MINI VISION STENT WAS IMPLANTED AT THE TARGET LESION. POST PROCEDURE, THE PATIENT WAS SENT TO THE RECOVERY ROOM AND THERE, HE COMPLAINED OF CHEST PAIN. PATIENT WAS TAKEN BACK TO THE CATH LAB AND THROMBOSIS WAS NOTED IN THE NEWLY IMPLANTED MINI VISION STENT. ADDITIONAL DILATATION WAS PERFORMED TO RE-OPEN THE STENT AND THE PATIENT WAS PLACED ON REOPRO (ABCIXIMAB). PATIENT WAS DISCHARGED TO HOME THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380354 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2042641

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CONCOMITANT MEDICAL DEVICES