BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3143582 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03473
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ESTIMATED IMPLANT DATE. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF RESTENOSIS IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS AN KNOWN ADVERSE EVENT. 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 WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED IN THE SAPHENOUS VEIN GRAFT (SVG). IT SHOULD BE NOTED THAT THE IFU STATES: THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. 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 ADDITIONAL PROMUS DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO UNSTABLE ANGINA, TWO PROMUS STENTS WERE IMPLANTED IN THE SAPHENOUS VEIN GRAFT (SVG) TO 1ST DIAGONAL ARTERY. ON (B)(6) 2013, THE PATIENT RETURNED WITH UNSTABLE ANGINA AND WAS RE-HOSPITALIZED. THE FOLLOWING DAY, ANGIOGRAPHY REVEALED 95% IN-STENT RESTENOSIS OF THE PREVIOUSLY DEPLOYED PROMUS STENTS. TREATMENT WAS PERFORMED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 4.0 MM NON-ABBOTT STENT. FOLLOWING POST-DILATATION, MINIMAL RESIDUAL STENOSIS WAS NOTED. THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED FROM HOSPITALIZATION THE NEXT DAY. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245154 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R STENT: PROMUS