BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 4173700 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06100
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    January 29, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATE CORRECTED FROM (B)(6) 2013 TO (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2013, THE PATIENT WAS HOSPITALIZED DUE TO ANGINA. TWELVE DAYS LATER, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT TWO LESIONS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND THE LEFT CORONARY ARTERY (LCA). THE UNSPECIFIED PROMUS ELEMENT (PE) DRUG ELUTING STENT WAS DEPLOYED TO THE RCA. FOLLOWING STENT PLACEMENT, A MILD DISSECTION WAS NOTED AT THE EDGE OF THE STENT. HENCE, THE PHYSICIAN TREATED THE DISSECTION BY PLACEMENT OF AN ADDITIONAL PE STENT TO THE LESION. THEN ANOTHER PE STENT WAS IMPLANTED IN THE LCA AND THE PROCEDURE WAS COMPLETED. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. IN (B)(6) 2013, THE PATIENT WAS HOSPITALIZED DUE TO ANGINA. TWELVE DAYS LATER, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT TWO LESIONS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND THE LEFT CORONARY ARTERY (LCA). THE UNSPECIFIED PROMUS ELEMENT (PE) DRUG ELUTING STENT WAS DEPLOYED TO THE RCA. FOLLOWING STENT PLACEMENT, A MILD DISSECTION WAS NOTED AT THE EDGE OF THE STENT. HENCE, THE PHYSICIAN TREATED THE DISSECTION BY PLACEMENT OF AN ADDITIONAL PE STENT TO THE LESION. THEN ANOTHER PE STENT WAS IMPLANTED IN THE LCA AND THE PROCEDURE WAS COMPLETED. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655288 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention