BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3961916 · Received July 28, 2014

    Report

    Report Number
    2134265-2014-04382
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    November 8, 2012
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-03540. (B)(4). IT WAS REPORTED THAT VESSEL JAILING OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA. PATIENT'S ELECTROCARDIOGRAM (ECG) REVEALED SMALL INFERIOR Q WAVES WITH NON-SIGNIFICANT ST DEVIATIONS AND STRONGLY POSITIVE TROPONIN LEVELS. PATIENT WAS DIAGNOSED WITH INFEROPOSTERIOR WALL MYOCARDIAL INFARCTION (MI) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. ALSO, PATIENT HAD A MODERATE LEFT VENTRICULAR DYSFUNCTION NOTED ON ECHOCARDIOGRAM AND WAS PRESCRIBED CARDIAC MEDICATIONS INCLUDING BETA BLOCKER, ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR AND STATIN. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A BIFURCATED DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH 100% STENOSIS, PRESENCE OF RESIDUAL THROMBUS, AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.4 MM. THE LESION WAS INITIALLY TREATED WITH PREDILATATION WHICH LED TO TRANSIENT OPENING OF VESSEL WHICH THEN THROMBOTICALLY OCCLUDED. HOWEVER, THE SITE CONFIRMED THAT THE RESIDUAL THROMBOTIC OCCLUSION WAS ONLY VISUALIZED POST PRE-DILATATION AND WAS NOT RELATED TO PRE-DILATATION. FOLLOWING THIS, THROMBECTOMY WAS PERFORMED, HOWEVER, THE VESSEL STILL APPEARED TO BE QUITE THROMBOTIC. SUBSEQUENTLY, A 2.50 X 28 MM PROMUS ELEMENT¿ PLUS STENT WAS DEPLOYED TO THE LESION. HOWEVER, POST DEPLOYMENT, THE SECOND OBTUSE MARGINAL (OM2) BRANCH WAS JAILED. THIS RESULTED IN OCCLUSION OF OM2 AND COMPLETE LOSS OF BLOOD FLOW TO THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO PERFORM INITIAL POST DILATATION USING A 3.5 X 12 MM NC QUANTUM APEX BALLOON, HOWEVER, DEVICE WAS NOT ABLE TO CROSS THE LESION AND THE DEVICE WAS EXCHANGED WITH 2.5 X 15 MM MAVERICK BALLOON. SUBSEQUENTLY, PT2 WIRE WAS INSERTED, HOWEVER, THIS ALSO COULD NOT CROSS THE LESION AND WAS EXCHANGED WITH A NON-BSC GUIDE WIRE AND A 0.014 NON-BSC EXTENSION WIRE. IN ADDITION, AFTER THE BALLOON ANGIOPLASTY WITH A 3.5 X 12 MM NC QUANTUM APEX BALLOON, A DISSECTION WAS NOTED HOWEVER, IT WAS CONFIRMED THAT IT WAS NOT A STENT EDGE DISSECTION, BUT RATHER AN UNCOVERED DISEASE WHICH WAS THE CAUSE FOR FURTHER STENT DEPLOYMENT AND IT WAS CLEARED BY THE PLACEMENT OF A 3.50 X 16 MM PROMUS ELEMENT¿ PLUS IN AN OVERLAPPING FASHION. PLACEMENT OF THE 3.50 X 16 MM STUDY STENT RESULTED IN THE JAILING OF THE FIRST OBTUSE MARGINAL (OM1) BRANCH AND SIGNIFICANT PLAQUE SHIFT INTO THE OM1 WAS NOTED. THE COMPLICATIONS OF JAILING AND PLAQUE SHIFT WERE TREATED USING KISSING BALLOON ANGIOPLASTY AND FINAL RESULTS WERE EXCELLENT. FOLLOWING POST DILATATION USING KISSING BALLOON TECHNIQUE, RESIDUAL STENOSIS WAS 0%. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL WITH RECOMMENDATION TO BE BACK FOR FUTURE PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RIGHT CORONARY ARTERY (RCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437648 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428250 15445036

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention