BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923398 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02704
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    March 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, RE-STENOSIS, AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS, A LENGTH OF 8 MM, AND REFERENCE VESSEL DIAMETER OF 2.50 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 2.50 X 12 MM STUDY STENT, AND POST DILATATION WITH 9% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, THE SUBJECT PRESENTED WITH THE COMPLAINT OF AN EPISODE OF EXERTIONAL CHEST PAIN. A STRESS ECHOCARDIOGRAM TEST ON (B)(6) 2010 INDICATED ANTERIOR WALL ISCHEMIA. ON (B)(6) 2010, 309 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT CORONARY ANGIOGRAPHY WHICH REVEALED:9 0% MID STENOSIS PRIOR TO PREVIOUSLY PLACED STENT; MILD DISEASE IN REMAINDER OF VESSEL. TOTAL LESION REVASCULARIZATION: THE MID LAD WAS TREATED WITH A 2.5 X 12 MM PROMUS STENT WITH LESS THAT 10% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2010. NO ADDITIONAL INFORMATION WAS PROVIDED. 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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R