BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK VISION CORONARY STENT SYSTEM

    MDR report key: 1764466 · Received July 16, 2010

    Report

    Report Number
    2024168-2010-01408
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    July 25, 2008
    Report Date
    June 23, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECTS OF RESTENOSIS, THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) FOR BOTH RX/OTW VISION AND RX/OTW MINI VISION. 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. BORIS T. IVANDIC, MD; ET AL (CLINICAL CHEMISTRY 2009; 55:6, 1171-1176). "DUAL ANTIPLATELET DRUG RESISTANCE IS A RISK FACTOR FOR CARDIOVASCULAR EVENTS AFTER PERCUTANEOUS CORONARY INTERVENTION".

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: STENT THROMBOSIS, MYOCARDIAL INFARCTION, REVASCULARIZATION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. THE AIM OF THIS STUDY WAS TO DETERMINE THE RELATIONSHIP OF DUAL ANTIPLATELET DRUG RESISTANCE TO CARDIOVASCULAR EVENTS FOLLOWING PERCUTANEOUS CORONARY INTERVENTION (PCI) DURING THE TIME PERIOD (B)(6) 2006 USING A TOTAL OF 141 BARE METAL (88 WERE VISION STENTS BY ABBOTT VASCULAR) AND 122 DRUG ELUTING STENTS (NON-ABBOTT). THERE WAS A MEDIAN NUMBER OF 1.4 STENTS IMPLANTED PER PATIENT. TWENTY TWO OF THE 182 PATIENTS STUDIED EXPERIENCED CARDIOVASCULAR EVENTS AFTER THE PCI CONSISTING OF 10 LATE STENT THROMBOSIS, 10 TARGET VESSEL REVASCULARIZATIONS, AND TWO ST ELEVATION MYOCARDIAL INFARCTIONS WITHIN A MEDIAL FOLLOW UP PERIOD OF 419 DAYS FROM THE INDEX PROCEDURE. SPECIFIC TREATMENT FOR THESE EVENTS WERE NOT SPECIFIED (SUCH AS REVASCULARIZATION VIA ANGIOPLASTY IN ADDITION TO STENTING.) THE ARTICLE DOES NOT DIRECTLY CORRELATE THE ADVERSE OUTCOMES TO A SPECIFIC DEVICE/BRAND/MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R| S