BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3192693 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04467
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2013-04470, 2134265-2013-04617. IT WAS REPORTED THAT SUBSEQUENT TO A CORONARY STENTING TREATMENT PROCEDURE, ANGINA, IN-STENT RESTENOSIS, AND PLAQUE SHIFTING OCCURRED. THE PATIENT PRESENTED ON JULY 2012 DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. TARGET LESION NO. 1 WAS A DE NOVO LESION LOCATED IN THE FIRST OBTUSE MARGINAL (OM) WITH 99% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25MM X 16MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION NO. 2 WAS A DE NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO FIRST OM WITH 70% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 3.00MM X 20MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL ONE DAY POST PROCEDURE. ON (B)(6) 2013, THE PATIENT PRESENTED DUE TO ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY REVEALED 80% OSTIAL STENOSIS OF THE PREVIOUSLY IMPLANTED PROMUS ELEMENT PLUS STENT LOCATED IN THE SVG TO FIRST OM AND WAS TREATED WITH ANGIOPLASTY AND PLACEMENT OF 4.00 X 16 PROMUS ELEMENT PLUS STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE IN-STENT RESTENOSIS OF ANASTOMOTIC SITE LESION OF THE OBTUSE MARGINAL WAS TREATED WITH BALLOON ANGIOPLASTY WITH 0% RESIDUAL STENOSIS. FOLLOWING POST-DEPLOYMENT OF THE 4.00MM X 16MM PROMUS ELEMENT PLUS STENT AND BALLOON ANGIOPLASTY, SOME PLAQUE SHIFT THROUGH THE SIDE OF SHRUT OF THE STENT HAS BEEN NOTED WITH SLUGGISH FLOW AND RETROGRADE FILLING DEFECT IN THE ACUTE MARGINAL BRANCH/CIRCUMFLEX ARTERY. THIS PLAQUE SHIFT HAS BEEN TREATED WITH INTEGRILIN. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2012 DUE TO STABLE ANGINA AND SUBSEQUENTLY FOUND TO BE ELEVATED CARDIAC ENZYMES. MYOCARDIAL INFARCTION (MI) WAS REPORTED AND THE PATIENT WAS THEN REFERRED FOR CARDIAC CATHETERIZATION. ON (B)(6) 2013, THE VESSEL THAT WAS TREATED WITH BALLOON ANGIOPLASTY WAS THE IN-STENT RESTENOTIC LESION AT THE DISTAL SEGMENT OF THE SAPHENOUS VEIN GRAFT (SVG) TO 1ST OBTUSE MARGINAL (OM) EXTENDING INTO THE PROXIMAL SEGMENT OF THE NATIVE 1ST OBTUSE MARGINAL BRANCH AND NOT THE ANASTOMOTIC SITE LESION OF THE OBTUSE MARGINAL THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PREVIOUSLY REPORTED IN-STENT RESTENOTIC LESION AT THE DISTAL SEGMENT OF THE SAPHENOUS VEIN GRAFT (SVG) TO 1ST OBTUSE MARGINAL (OM) EXTENDING INTO THE PROXIMAL SEGMENT OF THE NATIVE 1ST OBTUSE MARGINAL BRANCH WAS 99% STENOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292697 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416220 15133879

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention