BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3883728 · Received June 19, 2014

    Report

    Report Number
    2134265-2014-03540
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    November 8, 2012
    Report Date
    May 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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

    (B)(4).

    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: 2134265-2014-04382. IT WAS FURTHER REPORTED THAT PRIOR TO INDEX PROCEDURE, PATIENT'S TROPONIN LEVEL WERE STRONGLY POSITIVE WITH MODERATE LEFT VENTRICULAR DYSFUNCTION NOTED ON ECHOCARDIOGRAM. ALSO, THE TARGET LESION WAS LOCATED IN DISTAL LEFT CIRCUMFLEX (LCX) ARTERY WITH PRESENCE OF RESIDUAL THROMBUS AND NOT IN FIRST OBTUSE MARGINAL (OM) AS PREVIOUSLY REPORTED. 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, POST DEPLOYMENT OF A 2.50 X 28 MM PROMUS ELEMENT¿ PLUS STENT, THE OM2 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. THE DEVICE WAS EXCHANGED WITH A NON-BSC GUIDE WIRE AND A 0.014 NON-BSC EXTENSION WIRE AND ALSO ANOTHER PT2 GUIDE WIRE WAS USED THAT SUCCESSFULLY CROSSED THE LESION. IN ADDITION, IT WAS NOT A STENT EDGE DISSECTION NOTED 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. THE PATIENT WAS ALSO DISCHARGED WITH RECOMMENDATION TO BE BACK FOR FUTURE PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RIGHT CORONARY ARTERY (RCA).

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT VESSEL JAILING AND PLAQUE SHIFT OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS DIAGNOSED WITH INFEROPOSTERIOR WALL MYOCARDIAL INFARCTION (MI). CARDIAC CATHETERIZATION WAS RECOMMENDED. ELECTROCARDIOGRAM (ECG) REVEALED SMALL INFERIOR Q WAVES WITH NON-SIGNIFICANT ST DEVIATIONS. ALSO, PATIENT HAD A SIGNIFICANT LEFT VENTRICULAR DYSFUNCTION NOTED ON ECHOCARDIOGRAM WITH LVEF OF 40% AND WAS PRESCRIBED CARDIAC MEDICATIONS INCLUDING BETA BLOCKER, ANGIOTENSIN-CONVERTING ENZYME (ACE) INHIBITOR AND STATIN. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A BIFURCATED DE NOVO LESION LOCATED IN THE 1ST OBTUSE MARGINAL (OM1) WITH 100% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.4 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.50 X 28 MM AND 3.50 X 16 MM PROMUS ELEMENT¿ PLUS STENTS IN AN OVERLAPPING FASHION. POST DEPLOYMENT OF THE 3.50X16 PROMUS ELEMENT¿ PLUS STENT IN LEFT CIRCUMFLEX ARTERY (LCX), JAILING OF THE OM1 BRANCH AND SIGNIFICANT PLAQUE SHIFT INTO THE OM1 WAS NOTED AND THIS WAS TREATED WITH KISSING BALLOON ANGIOPLASTY. FOLLOWING POST DILATATION USING KISSING BALLOON TECHNIQUE, RESIDUAL STENOSIS WAS 0% AND FINAL RESULTS WAS EXCELLENT. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359912 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416350 15108852

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention