BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1033916 · Received April 24, 2008

    Report

    Report Number
    2024168-2008-00342
    Event Type
    Death
    Date Received
    April 24, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND MULTI-LINK RX VISION CORONARY STENT SYSTEM INDICATED IS BEING FILED UNDER THE SAME MFR NUMBER. RESULT AND CONCLUSION SUMMATION-PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. THERE WAS NO REPORTED DEVICE MALFUNCTIONS AT THE TIME OF THE PROCEDURE. ISCHEMIA AND DEATH, AS LISTED IN THE DEVICE RISK ASSESSMENT AND INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. THESE KNOWN PATIENT EFFECTS ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. ALTHOUGH A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE RELATIONSHIP BETWEEN THE REPORTED PATIENT EFFECTS AND THE DEVICES, THERE ARE NO INDICATIONS OF ANY PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH, REPORTING RATIONALE: DEATH, DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE PATIENT WAS AN ACUTE AMI PATIENT. JUST AFTER THE TWO STENTS WERE IMPLANTED THERE WAS SLOW FLOW IN THE ARTERY AND THE PATIENT DIED ON THE CATH LAB. TABLE. 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 7070931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death MULTI-LINK RX VISION CORONARY STENT SYSTEM| DIL CATH: VOYAGER| GUIDE CATH: EBU| GUIDE WIRE: BMW| (PART# 1007842-28 LOT# 7062731)