BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2369943 · Received December 13, 2011

    Report

    Report Number
    2024168-2011-08367
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. THE ADDITIONAL PROMUS STENT AND THE ZETA STENT ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED HYPERSENSITIVITY IS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. IS SHOULD BE NOTED THAT THE IFU STATES THAT 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 (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.25 MM TO 4.25 MM. THE IMPLANTATION OF THE STENT TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, A ZETA STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. ON (B)(6) 2011, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION FOR 80-85% IN-STENT RESTENOSIS OF A 3.5X28 ZETA STENT AND A DE NOVO LESION DISTAL TO THE STENTED SEGMENT. THE PATIENT WAS TREATED WITH TWO OVERLAPPING PROMUS STENTS, A 3.5X28 PROMUS STENT INSIDE THE ZETA STENT AND A 3.5X15 PROMUS STENT TO COVER THE DISTAL DE NOVO LESION. WITHIN 24-36 HOURS, THE PATIENT DEVELOPED A CUTANEOUS ITCHY RASH ON THE TRUNK, ARMS AND LEGS. THE PATIENT RECEIVED A NUMBER OF UNSPECIFIED MEDICATIONS DURING THE PROCEDURE BUT WAS DISCHARGED WITH ONLY THE USUAL MEDICATIONS. THE PATIENT HAS RECEIVED CONTRAST MEDIA SEVERAL TIMES IN THE PAST WITHOUT ANY ALLERGIC REACTION AND HAS NO DOCUMENTED PRIOR REACTION TO ADDITIONAL MEDICATIONS WHILE HOSPITALIZED. THE PATIENT WAS TREATED WITH BENADRYL AND IS ASYMPTOMATIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: PROMUS, ZETA