BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140426 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03415
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) - INCORRECT ANATOMY, NON-DE NOVO LESION. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU)AS KNOWN PATIENT EFFECTS. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN A SAPHENOUS VEIN GRAFT (SVG) LESION. IT SHOULD BE NOTED THAT THE IFU STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES: SAFETY AND EFFECTIVENESS OF THE PROMUS STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. 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, DESIGN, OR LABELING. THE ADDITIONAL PROMUS DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION WAS RECEIVED WHICH STATES, THE SUBJECT PRESENTED TO THE PRIMARY CARE PHYSICIAN ON (B)(6) 2013 WITH A 1 MONTH HISTORY OF ANTERIOR CHEST PAIN WITH BILATERAL RADIATION TO THE THROAT AND DOWN THE RIGHT ARM. A NUCLEAR STRESS TEST WAS PERFORMED ON (B)(6) 2013 WHICH SHOWED REVERSIBLE DISEASE INFERIORLY AND INFEROLATERALLY. ON (B)(6) 2013 THE SUBJECT WAS TAKEN TO THE CATH LAB AS AN OUTPATIENT AND FOUND TO HAVE PROGRESSIVE DISEASE IN THE SAPHENOUS VEIN GRAFT (SVG) - DIAGONAL WITH 50% IN-STENT RESTENOSIS OF THE PROMUS STENT IMPLANTED ON (B)(6) 2010. THE VESSEL ALSO HAD A 70% STENOSIS AND AN 80% STENOSIS PROXIMAL, AND A 70% STENOSIS DISTAL TO THE STENT. THE VESSEL WAS TREATED WITH 3 DRUG ELUTING STENTS. THERE WAS NO REPORTED TORTUOSITY OR CALCIFICATION NOTED IN THE VESSEL. ADDITIONALLY, THE 2.5 X 28 MM PROMUS STENT PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) ON (B)(6) 2010 ALSO SHOWED MILD IN-STENT RESTENOSIS OF 30% AT THE DISTAL END OF THE STENT AND WAS TREATED. THE OUTCOME OF THE EVENT WAS NOTED AS RECOVERED OR RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DUE TO STABLE ANGINA, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF TWO DRUG ELUTING STENTS ONE EACH TO THE MID LEFT ANTERIOR DESCENDING ARTERY AND THE FIRST DIAGONAL ARTERY. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON (B)(6) 2010, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. THE SUBJECT WAS NOT RANDOMIZED WITH THE REASON 'INTERRUPTION > 14 DAYS OF PRESCRIBED THIENOPYRIDINE'. ON (B)(6) 2013, THE SUBJECT EXPERIENCED THE EVENT OF UNSTABLE ANGINA (B)(6) DAYS FOLLOWING THE INDEX PROCEDURE. THE EVENT WAS REPORTED WITH THE SERIOUS CRITERIA OF INITIAL OR PROLONGED HOSPITALIZATION AND THE SUBJECT POSSIBLY UNDERWENT REVASCULARIZATION OF THE 1ST DIAGONAL BRANCH OF THE SAPHENOUS VEIN GRAFT (SVG]. THE OUTCOME OF THE EVENT WAS NOTED AS RECOVERED OR RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241953 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0012761

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R