BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1242212 · Received November 19, 2008

    Report

    Report Number
    2024168-2008-01180
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. DISSECTION, ISCHEMIA, AND ANGINA AS LISTED IN THE DEVICE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EFFECTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF PROD QUALITY ISSUE. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE LOT HISTORY RECORD REVIEW DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS AND THERE HAVE BEEN NO OTHER COMPLAINTS WITH THIS PART AND LOT NUMBER. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED COMPLAINTS CANNOT BE DETERMINED. THE REPORTED PT EFFECTS ARE KNOWN ADVERSE EFFECTS OF CORONARY STENTING AND NOT NECESSARILY A SDS QUALITY PROBLEM.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: REQUIRED MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THERE WAS A DISSECTION OF THE ANTERIOR DESCENDING ARTERY AFTER THE RX VISION BALLOON WAS INFLATED TO 16 ATM. THE PT ALSO PRESENTED WITH ISCHEMIA AND ANGINA DURING THIS TIME. A SECOND VISION STENT WAS IMPLANTED TO TREAT THE DISSECTION. NO ADD'L EVENT OR PT INFO 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 7121331

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention STENT: VISION| GUIDE WIRE: BMW| DILATATION CATHETER: MAVERICK| GUIDE CATHETER: IMPULSE