BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160457 · Received July 13, 2011

    Report

    Report Number
    2024168-2011-04949
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 22, 2011
    Report Date
    June 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS ARE LISTED IN THE PROMUS INSTRUCTION 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 OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.75 X 12 MM PROMUS AND THE 2.75 X 28 MM PROMUS 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. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO ACUTE CORONARY SYNDROME, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF A 2.5 X 12 MM PROMUS STENT TO THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. THE PATIENT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION ON (B)(6) 2010. IT WAS ALSO REPORTED THAT ON (B)(6) 2010, AT ANOTHER FACILITY, THE PATIENT HAD A 2.75 X 12 MM PROMUS AND A 2.75 X 28 MM PROMUS STENT IMPLANTED IN THE MID-DISTAL LAD. FINAL ANGIOGRAM SHOWED WELL-POSITIONED AND WELL-EXPANDED STENTS WITH A TIMI 3 FLOW DOWN THE ENTIRE LAD SYSTEM. ON (B)(6) 2011, THE PATIENT PRESENTED WITH AN ONSET OF UNSTABLE ANGINA. CARDIAC ENZYMES WERE REPORTED AS NEGATIVE. CATHERIZATION WAS PERFORMED AND NOTED IN-STENT RESTENOSIS OF THE LAD. A 3.5 X 12 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LAD. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2011. NO ADVERSE PATIENT SEQUELAE WERE REPORTED. 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 0071341

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R STENTS: PROMUS (2.75X12, 2.75X28)