BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160117 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02834
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH STENT DAMAGE. STRUT ROWS AT THE DISTAL END OF THE STENT WERE RAISED AND MISALIGNED. STRUT ROWS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED AND STRETCHED OVER THE PROXIMAL MARKERBAND. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN PLACED A 3.0X20MM PROMUS IN THE LEFT MAIN (LM) TO LAD. PHYSICIAN THEN ATTEMPTED TO PLACE THE 2.5X38MM PROMUS ELEMENT IN THE MID LAD, THE STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS THE PLACED STENT. UPON REMOVAL OF THE SDS DAMAGE TO THE STENT EDGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH 2.5X24MM, 2.25X24MM AND 2.25X20MM UNKNOWN STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN PLACED A 3.0X20MM PROMUS IN THE LEFT MAIN (LM) TO LAD. PHYSICIAN THEN ATTEMPTED TO PLACE THE 2.5X38MM PROMUS ELEMENT IN THE MID LAD, THE STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS THE PLACED STENT. UPON REMOVAL OF THE SDS DAMAGE TO THE STENT EDGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH 2.5X24MM, 2.25X24MM AND 2.25X20MM UNKNOWN STENTS. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 14225099

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR STENT: PROMUS ELEMENT 3.0X20MM