BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER¿

    MDR report key: 6146672 · Received December 5, 2016

    Report

    Report Number
    2134265-2016-11046
    Event Type
    Injury
    Date Received
    December 5, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE/ABSTRACT CITATION: ISHIKAWA T, KIMURA H, NAKATA K, KOMUKAI K. RECOIL OF PROMUS PREMIER® 4-MONTH AFTER PLACEMENT FOR OSTIAL LESION OF RIGHT CORONARY ARTERY [ABSTRACT]. J AM COLL CARDIOL. 2016; 67 (16 SUPPL. 1): S278-S9. 21ST CARDIOVASCULAR SUMMIT: TRANSCATHETER CARDIOVASCULAR THERAPEUTICS (B)(6), TCTAP 2016 (B)(6) 2016-04-26 TO 2016-04-29. IF IMPLANTED, GIVE DATE: (B)(6) 2014. EVENT DATE: (B)(6) 2015. (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ABSTRACT THAT RECOIL AND RESTENOSIS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796404 PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention