BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 6146678 · Received December 5, 2016

    Report

    Report Number
    2134265-2016-11417
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Report Date
    November 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ABSTRACT CITATION HIROMASA T.ET. AL. ¿INCIDENCE AND CLINICAL IMPACT OF LONGITUDINAL STENT DEFORMATION AFTER THE PROMUS ELEMENT PLATINUM CHROMIUM-EVEROLIMUS ELUTING STENT IMPLANTATION¿ [ABSTRACT]. EUR HEART J. 2016; 37 SUPPLEMENT 1: 667. EUROPEAN SOCIETY OF CARDIOLOGY, ESC CONGRESS 2016 ROME, ITALY 2016-08-27 TO 2016-08-31. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME ARTICLE AS MDR ID#2134265-2016-11057, 2134265-2016-11416, 2134265-2016-11418, 2134265-2016-11419, 2134265-2016-11420, 2134265-2016-11421, 2134265-2016-11422, 2134265-2016-11423, 2134265-2016-11424, 2134265-2016-11425, 2134265-2016-11426, 2134265-2016-11427, 2134265-2016-11428, 2134265-2016-11429, 2134265-2016-11430, 2134265-2016-11431. IT WAS REPORTED VIA LITERATURE ABSTRACT THAT LONGITUDINAL STENT DEFORMATION OCCURRED. THE PROMUS ELEMENT PLATINUM-CHROMIUM EVEROLIMUS-ELUTING STENT (PTCR-EES) HAS A NOVEL METAL AND STENT DESIGN INTENDED TO IMPROVE DELIVERABILITY, COMFORMABILITY, AND RADIAL STRENGTH, WHEREAS SUCH FEATURES MIGHT HAVE THE TRADE-OFF OF REDUCING LONGITUDINAL STENT STRENGTH, WHICH WOULD ACCOUNT FOR THE OCCURRENCE OF LONGITUDINAL STENT DEFORMATION (LSD) AS REPORTED PREVIOUSLY. HOWEVER, THE INCIDENCE AND CLINICAL IMPACT OF LSD AFTER PTCR-EES IMPLANTATION IN CLINICAL PRACTICE HAVE NOT BEEN FULLY EVALUATED. A TOTAL OF 804 PATIENTS WITH 1051 LESIONS UNDERGOING PTCR-EES IMPLANTATION BETWEEN MARCH 2012 AND AUGUST 2013 WERE ANALYZED. LSD WAS DEFINED AS THE DISTORTION OR SHORTENING AND ELONGATION OF A STENT IN THE LONGITUDINAL AXIS FOLLOWING SUCCESSFUL STENT DEPLOYMENT. WE ASSESSED THE INCIDENCE OF LONGITUDINAL STENT DEFORMATION AND CUMULATIVE INCIDENCE OF MAJOR ADVERSE CARDIAC EVENTS (MACE), DEFINED AS A COMPOSITE OF CARDIAC DEATH, NON-FATAL MYOCARDIAL INFARCTION, DEFINITE STENT THROMBOSIS, AND CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION WITHIN 2-YEAR. OF 804 PATIENTS WITH 1051 LESIONS, WE PERFORMED AN INTRAVASCULAR ULTRASOUND (IVUS) AND POST-DILATATION IN 787 PATIENTS (97.9%) WITH 1031 LESIONS (98.1%) AND IN 407 PATIENTS (50.6%) WITH 512 LESIONS (48.7%). IN THE LSD GROUP, IVUS AND POST-DILATATION WERE PERFORMED IN ALL PATIENTS. LSD WAS OBSERVED IN 17 PATIENTS (2.1%) WITH 17 LESIONS (1.6%). THE MECHANISM OF LSD WAS DUE TO THE FOLLOWING REASONS: COMPRESSION BY POST-DILATATION BALLOONS (N=2, 11.8%), ENTRAPPED IVUS (N=12, 70.6%) AND PULL BACKED JAILED GUIDE WIRE (N=3, 17.6%). AT 2-YEAR, THE CUMULATIVE INCIDENCE OF MACE, CARDIAC DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS AND CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE LSD AND NON-LSD GROUPS (6.3% VS. 6.4%, P=0.84; 0% VS. 0.9%, P=0.76; 0% VS. 0.9%, P=0.76; 0% VS. 0.6%, P=0.77; 6.3% VS. 5.8%, P=0.77, RESPECTIVELY). CONCLUSIONS: LSD AFTER PTCR-EES IMPLANTATION OCCURS IN 1.6% OF LESIONS. HOWEVER, LSD IS NOT ASSOCIATED WITH MACE WITHIN 2-YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795982 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1