BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1200667 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00974
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION-PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT IS POSSIBLE THAT THE STENT MAY NOT HAVE BEEN FULLY EXPANDED DURING THE INITIAL PROCEDURE, THEREBY CONTRIBUTING TO THE THROMBOSIS AND SUBSEQUENT ANGINA THAT THE PATIENT PRESENTED WITH A WEEK LATER. THROMBOSIS AND ANGINA AS LISTED IN THE DEVICE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EFFECTS ASSOCIATED WITH CORONARY STENTING. THESE KNOWN PATIENT EFFECTS ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. NO DEVICE ISSUE DURING THE PROCEDURE WAS REPORTED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTIONS HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2008, A 3.0 X 23 MM VISION AND A 2.75 X 23 MM ZETA WERE IMPLANTED AT A LESION LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING. FIVE DAYS LATER, THE PATIENT COMPLAINED OF CHEST PAIN AND A CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED. AS A RESULT, THE THROMBOSIS WAS CONFIRMED AROUND THE VISION STENT. SO, THE THROMBOSIS WAS SUCTIONED AND ANOTHER COMPANY'S BALLOON WAS INFLATED AT THE LESION WITH A HIGH PRESSURE. 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 ABBOTT VASCULAR-CARDIAC THERAPIES NA 704043Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention