BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3408632 · Received October 14, 2013

    Report

    Report Number
    2024168-2013-06514
    Event Type
    Injury
    Date Received
    October 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    April 20, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NON DE NOVO LESION. THE 95% INSTENT STENOSIS OF THE PREVIOUSLY DEPLOYED 2.5 X 8 MM PROMUS STENT IN THE DIAGONAL 1 WAS TREATED BY USING BALLOON ANGIOPLASTY. ON (B)(6) 2013, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WERE NO REPORTED PRODUCT DEFICIENCIES AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECTS OF ANGINA, STENOSIS/RESTENOSIS, AND OCCLUSION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009 THE TARGET LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) WAS TREATED WITH A 3.0 X 32 MM NON-ABBOTT STENT. ON (B)(6) 2012, THE MLAD HAD 90% IN-STENT STENOSIS AND WAS TREATED WITH A 2.5 X 8 MM PROMUS STENT. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2012 WITH PLACEMENT OF A 3.0 X 32 MM NON-ABBOTT STUDY STENT. IT WAS NOTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY; CARDIAC CATHETERIZATION ANGIOGRAPHY REVEALED 20% STENOSIS OF THE LEFT MAIN CORONARY ARTERY (LMCA), A PATENT PROXIMAL LAD OF A PREVIOUSLY DEPLOYED UNSPECIFIED STENT AND THE MLAD OCCLUDED. THE OCCLUSION OF THE MLAD WAS TREATED USING BALLOON ANGIOPLASTY. ON (B)(6) 2013, THE SUBJECT AGAIN PRESENTED WITH UNSTABLE ANGINA AND WAS HOSPITALIZED. CARDIAC CATHETERIZATION ANGIOGRAPHY REVEALED 10% STENOSIS OF THE LMCA, OCCLUDED DISTAL LAD, COMPLEX PUMP PAIL HANDLE LESION IN THE MID TO DISTAL SEGMENT OF THE DIAGONAL, 40% STENOSIS OF THE CIRCUMFLEX (LCX) WITH AN OCCLUDED OBTUSE MARGINAL 2 (OM2), PATENT DIFFUSELY DISEASED DISTAL RIGHT CORONARY ARTERY (DRCA), AND A 95% STENOSIS SAPHENOUS VEIN GRAFT (SVG) TO THE OM AND 60-70% STENOSIS NEAR THE OSTIUM. ON (B)(6) 2013, 356 DAYS POST INDEX PROCEDURE, THE 95% STENOSED SVG TO OM2 WAS TREATED WITH PLACEMENT OF A 3.0 X 38 MM NON-ABBOTT STENT AND AN INTIMAL TEAR TYPE DISSECTION WAS NOTED. A 3.5 X 8 MM PROMUS STENT WAS USED FOR TREATMENT. THE 60-70% OSTIUM STENOSIS WAS TREATED WITH PLACEMENT OF A 3.5 X 16 MM NON-ABBOTT STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525893 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R