BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2370037 · Received December 13, 2011

    Report

    Report Number
    2024168-2011-08371
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 22, 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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF HYPERSENSITIVITY/ALLERGIC REACTION IS LISTED IN THE PROMUS INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    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