BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1800543 · Received August 12, 2010

    Report

    Report Number
    2024168-2010-01647
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 5, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, ARRHYTHMIAS (VENTRICULAR TACHYCARDIA), MYOCARDIAL INFARCTION (MI), AND THROMBOSIS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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

    ADVERSE EVENT: THROMBOSIS/ACUTE MYOCARDIAL INFARCTION. ONSET OF ADVERSE EVENT: 2 MONTHS POST-PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, DUE TO STABLE ANGINA AND A POSITIVE STRESS TEST, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF 2 NON-ABBOTT DRUG ELUTING STENTS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) FOR AN IN-STENT RESTENOSIS AND IN THE MID RCA. A PROMUS 3.0 X 15 MM STENT WAS IMPLANTED IN THE OSTIUM OF THE RCA. THE PATIENT WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2010, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND ELEVATED CARDIAC ENZYMES. ANGIOGRAPHY REVEALED THROMBOSIS AND 100% OCCLUSION IN THE PROXIMAL RCA. A THROMBECTOMY WAS DONE AND MULTIPLE BALLOONS WERE USED TO OPEN THE RCA. THE CHEST PAIN RE-OCCURRED AND THE PATIENT RETURNED TO THE CATHERIZATION LABORATORY THE NEXT MORNING AND TWO STENTS WERE DEPLOYED IN THE CIRCUMFLEX ARTERY. THE PATIENT TOLERATED THE PROCEDURE WELL AGAIN. THE PATIENT WAS WATCHED, BUT DEVELOPED POLYMORPHIC NONSUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT WAS DISCHARGED ON (B)(6) 2010, WITH AN EXTERNAL DEFIBRILLATOR. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9083161

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S APEX 9 (X2)| OTHER: EXPORT CATHETER| QUANTUM 3.5X20,| GUIDE WIRE: 0.014 BMW| GUIDE CATH: 6F XP 3.5| DILATATION CATHETER: ANGIOSCULPT (X2)