BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2133938 · Received June 20, 2011

    Report

    Report Number
    2024168-2011-04346
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED RESTENOSIS IS LISTED IN THE PROMUS INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RE-STENOSIS OF A PROMUS STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH MODERATE TORTUOSITY AND MILD CALCIFICATION. A 3.0 X 23 PROMUS STENT WAS ADVANCED AND A 2.5 X 28 PROMUS WAS ADVANCED; HOWEVER, BOTH STENTS WERE UNABLE TO CROSS TO THE LESION. A SHORTER PROMUS STENT WAS ADVANCED AND IMPLANTED SUCCESSFULLY. IT WAS NOTED THAT A SMALL AREA OF THE LESION WAS LEFT UNCOVERED. 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 0070161

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R