BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923474 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02718
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    March 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA
    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 AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IN THIS CASE, THE PATIENT WAS HOSPITALIZATION AND WAS TREATED WITH ADDITIONAL 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 TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT THE FIRST TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 98% STENOSIS. THE SECOND TARGET LESION WAS LOCATED IN THE LATERAL FIRST OBTUSE MARGINAL (1ST OM) WITH 80% STENOSIS. PREDILATATION WAS PERFORMED PRIOR TO PLACEMENT OF THE (B)(4) STENTS. A 2.50 X 28 MM STUDY STENT WAS PLACED IN THE LAD, AND POST-DILATATION PERFORMED WITH 0% RESIDUAL STENOSIS. THE 1ST OM WAS TREATED WITH A 2.50 X 12 MM AND A 2.50 X 12 MM STUDY STENTS. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. SUBJECT WAS DISCHARGED (B)(4) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2010, 271 DAYS POST INDEX PROCEDURE, CORONARY ANGIOGRAPHY WAS PERFORMED DUE TO COMPLAINTS OF CHEST PAIN WITH AN ABNORMAL STRESS ECHO. THE PROCEDURE REVEALED 90% STENOSIS JUST PROXIMAL TO THE PREVIOUSLY DEPLOYED STENT IN THE LAD. THE PROXIMAL LAD WAS TREATED WITH THE PLACEMENT OF A 2.5 X 12 PROMUS STENT, FOLLOWED BY POST-DILATATION. LESION STENOSIS AFTER STENTING WAS 0%. 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 8100961

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R PROMUS (2 - 2.5X12 MM)