BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3884684 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03943
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    November 13, 2013
    Report Date
    May 28, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE MULTI-LINK VISION CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH CORONARY STENTING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED CHEST PAIN AND SHORTNESS OF BREATH UPON COMING HOME FROM WORK. THE PATIENT SUFFERED CARDIAC ARREST IN THE EMERGENCY ROOM PARKING LOT, CPR WAS INITIATED AND THE INITIAL RHYTHM WAS V-FIB. AFTER MULTIPLE DEFIBRILLATIONS, RHYTHM SHOWS DIFFUSE ST ELEVATION. THE PATIENT WAS TRANSFERRED EMERGENTLY TO OUR FACILITY FOR CATH AND PERCUTANEOUS CORONARY INTERVENTION. FILMS REVEALED A 100% OCCLUSION WITH THROMBUS OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THROMBECTOMY WAS PERFORMED WITH MULTIPLE PASSES RESTORING FLOW. PREDILATATION WAS PERFORMED WITH A 2.5X20 MM TREK AND A 2.75X28 MM MULTI LINK VISION STENT WAS DEPLOYED WITH GOOD RESULTS. MEDICINES INCLUDED HEPARIN, ASA, ANGIOMAX, INTEGRILIN AND AN INITIAL BRILINTA DOSE. THEN PLAVIX WAS ADMINISTERED TO CONTINUE THROUGH REST OF HOSPITAL STAY. THE PATIENT WAS STILL HOSPITALIZED WHEN ST ELEVATIONS RETURNED. THE PATIENT WAS TAKEN TO THE CARDIAC CATH LAB EMERGENTLY, AND FILMS REVEAL A 100% THROMBOTIC OCCLUSION OF THE PROXIMAL PORTION OF PREVIOUSLY PLACED STENT. INITIAL PREDILATION WITH A 2.0X30 MM MINI TREK BALLOON CATHETER AND THROMBECTOMY WITH MULTIPLE PASSES WAS PERFORMED. A SERIES OF INFLATIONS USING 3 DIFFERENT SIZED NON-ABBOTT BALLOON CATHETER WAS PERFORMED AND AN ADDITIONAL 4.0X28 MM MULTI LINK VISION STENT WAS DEPLOYED THROUGH THE PREVIOUSLY PLACED STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 WITH MEDICINES INCLUDING ASA AND BRILINTA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361554 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3052641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R