BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3043175 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02218
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    April 2, 2012
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    (B)(4). SAME CASE AS 2134265-2013-02217; 2134265-2013-02221; 2134265-2013-02751. SAME PATIENT AS 2134265-2013-01970 AND 2134265-2013-02216. IT WAS REPORTED THAT POST A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. LESION 1 WAS A DE NOVO LONG LESION EXTENDING FROM MID LEFT ANTERIOR DESCENDING (LAD) TO DISTAL LAD WITH 100% STENOSIS AND WAS 58 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF 2.25 MM X 32 MM AND 2.50 MM X 28 MM ION STENTS IN AN OVERLAPPING MANNER. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. THE PATIENT RETURNED TO THE CATHETERIZATION LAB ((B)(6) 2012) FOR STENT PLACEMENT IN THE PROXIMAL SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE TARGET LESION WAS A DE NOVO OSTIAL LESION LOCATED IN THE PROXIMAL SVG TO R-PDA WITH 95% STENOSIS AND WAS 33 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF 3.00 MM X 38 MM AND 3.00 MM X 16 MM ION STENTS IN AN OVERLAPPING MANNER. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. FOLLOWING PLACEMENT OF THE 3.0 X 38 MM ION STENT, THERE WAS A TRANSIENT NO-FLOW OBSERVED, WHICH WAS TREATED WITH THE ADMINISTRATION OF IC NITROGLYCERINE. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. LINEAR DISSECTION CAUSED BY THE PLACEMENT OF 3.00 X 16 MM PROMUS ELEMENT PLUS STENT PRIOR TO THE INDEX PROCEDURE WHICH WAS TREATED WITH THE PLACEMENT OF AN ADDITIONAL 2.75 MM X 24 MM NON-STUDY PROMUS ELEMENT PLUS STENT. DURING THE STAGED PROCEDURE, THE PATIENT EXPERIENCED A BRIEF EPISODE OF VENTRICULAR FIBRILLATION ARREST AND WAS IMMEDIATELY DEFIBRILLATED, WITH RETURN TO SINUS RHYTHM. DURING THE STAGED PROCEDURE, THE LUGE WIRE WAS INSERTED IN THE SVG GRAFT WHICH WAS UNABLE TO ACCESS THE VESSEL AND HENCE WAS REMOVED. FINALLY A HI-TORQUE WIRE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146503 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911624270 14850307

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention LUGE GUIDE WIRE| MACH 1 GUIDE CATHETER| 3.00X38MM ION STENT| 3.00X16MM PROMUS ELEMENT PLUS STENT| 2.50X28MM ION STENT| 2.25X32MM ION STENT| 3.00X16MM ION STENT