BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895367 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00033
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    September 6, 2011
    Report Date
    December 11, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. 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. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE ADDITIONAL PROMUS IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION, STENOSIS/RESTENOSIS AND ANGINA ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED TO TREAT A LESION IN A SAPHENOUS VEIN GRAFT (SVG). IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: PROMUS 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: THE 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 DEVIATIONS DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, TWO PROMUS STENTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2011, THE PATIENT PRESENTED WITH A MYOCARDIAL INFARCTION. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILING ADDITIONAL INFORMATION REPORTED THAT THE TWO STENTS IMPLANTED ON (B)(6) 2010 WERE A 3.5 X 12 MM PROMUS STENT AND A 2.75 X 15 MM PROMUS STENT. THE STENTED LESIONS WERE IN A SAPHENOUS VEIN GRAFT (SVG) FROM THE AORTA TO THE LEFT ANTERIOR DESCENDING ARTERY, AND A LESION IN A SVG FROM THE AORTA TO THE OBTUSE MARGINAL. ON (B)(6) 2011, THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION AND STATED THAT TWO WEEKS PRIOR HE STARTED HAVING CHEST DISCOMFORT, WHICH HE WAS TRYING TO CONTROL WITH NITROGLYCERIN. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO ANOTHER HOSPITAL. ON (B)(6) 2011, REPEAT ANGIOGRAPHY WAS PERFORMED. THE PATIENT RECEIVED TWO STENTS AND WAS TREATED MEDICALLY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S STENT: PROMUS