BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 1030837 · Received April 17, 2008

    Report

    Report Number
    2024168-2008-00301
    Event Type
    Death
    Date Received
    April 17, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION-EKG/ECG CHANGES, OCCLUSION, THROMBOSIS, AND DEATH AS LISTED IN THE DEVICE RAM AND IFU ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ANGINA AND CARDIAC ARREST ARE POTENTIAL EFFECTS AND ARE LIKELY THE RESULTS OF THE EKG/ECG CHANGES, OCCLUSION, AND THROMBOSIS. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED PT EFFECTS AND THEIR RELATIONSHIP TO THE DEVICE. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM QUALITY PROBLEM.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH REPORTING RATIONALE: DEATH DEVICE ISSUE: NONE IT WAS REPORTED THAT THE OTW VISION STENT WAS DEPLOYED IN A LESION IN THE MID CIRCUMFLEX. AFTER THE PROCEDURE WAS OVER, ON ANGIOGRAPHY, EVERYTHING LOOKED GOOD. THE PT WAS TRANSFERRED FROM THE CATH LAB TABLE TO A BED TO TAKE HIM TO RECOVERY; HOWEVER, WHILE ON THE BED, STILL IN THE CATH LAB, THE PT EXPERIENCED ST DEPRESSION AND THEN ST ELEVATIONS AND CHEST PAIN. THE PT WAS PUT BACK ON THE TABLE AND ON ANGIOGRAPHY IT COULD BE SEEN THAT THE LEFT MAIN HAD TOTALLY SHUT DOWN. THE PT WAS SENT FOR SURGERY; HOWEVER, IT IS UNK IF THE PT ACTUALLY REACHED THE OR BEFORE HE EXPIRED, OR IF IT WAS DURING SURGERY THAT THE PT EXPIRED. CPR WAS BEING ADMINISTERED WHILE THE PT WAS ON THE WAY TO THE OR. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK OTW VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010231

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death