BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961918 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00336
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 21, 2010
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. MYOCARDIAL INFARCTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). 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).

    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. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DEVICE INVOLVED IN THE EVENT WAS NOT A PROMUS STENT; IT WAS A NON-ABBOTT STENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT ON (B)(4) 2009, THE TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH 95% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X18 MM PROMUS STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, 579 DAYS POST INDEX PROCEDURE, THE PATIENT HAD AN EVENT OF NON-ST ELEVATION MYOCARDIAL INFARCTION AND WAS ADMITTED TO THE HOSPITAL AND MEDICATION WAS GIVEN. THE OUTCOME IS UNKNOWN. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. 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.

    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 80 YR Hospitalization| S