BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3042943 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02102
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF EMBOLISM AND ISCHEMIA AS LISTED IN THE PROMUS EVEROLIMUS ELUTING STENT SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE PATIENT EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. IT WAS REPORTED THAT THE 3.0X12MM PROMUS STENT DELIVERY SYSTEM WAS USED TO TREAT A 90% STENOSED LESION IN THE SAPHENOUS VEIN GRAFT. IT SHOULD BE NOTED IN THE IFU STATES: THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (PROMUS STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS WITH REFERENCE DIAMETERS OF 2.25 MM TO 4.25 MM.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, POST DEPLOYMENT OF A 3.0X12 PROMUS STENT IN A 90% STENOSED LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO DIAGONAL CORONARY ARTERY, DISTAL EMBOLIZATION OF PLAQUE TO THE DISTAL NATIVE VESSEL WAS NOTED. AN UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED TO THE DISTAL VESSEL WITH EMBOLUS, FOLLOWED BY 'DOTTERING' (CREATING A SMALL PATHWAY) USING A 1.5MM BALLOON DILATATION CATHETER (BDC). MULTIPLE DOSES OF NITROGLYCERIN WERE ALSO ADMINISTERED TO THE PATIENT TO TREAT THE EMBOLUS, HOWEVER, A SLOW FLOW OF TIMI 1 WAS STILL PRESENT. THE PROCEDURE WAS TERMINATED DUE TO THE SIZE OF THE VESSEL. POST STENT DEPLOYMENT, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY ((B)(6) 2013), AS THE EVENT HAD RESOLVED WITHOUT RESIDUAL EFFECTS, THE PATIENT WAS DISCHARGED WITH PRESCRIBED ASPIRIN AND PRASUGREL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146886 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention