BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061579 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01290
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 FLARED. STRUT ROWS AT THE PROXIMAL END OF THE STENT WERE MISALIGNED DISTALLY TO THE STENT. THE APPEARANCE OF THE FLARED DISTAL STRUTS WOULD SUGGEST THAT THE INFLATION PROCEDURE HAD BEGUN. THE OUTER DIAMETER (OD) OF THE STENT DAMAGE AT THE DISTAL END MEASURED AT 1.57MM. THE OUTER DIAMETER (OD) OF THE STENT DAMAGE AT THE PROXIMAL END MEASURED AT APPROXIMATELY 1.90MM. THE OD OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT WAS MEASURED AT APPROXIMATELY 1.16MM. THE STENT PROTECTOR WAS RETURNED RESTING ON THE LUMEN JUST DISTAL TO THE PROXIMAL END OF THE DAMAGED STENT. THE STENT PROTECTOR WAS UNDAMAGED BUT COULD NOT BE REMOVED DUE TO THE DAMAGE TO THE STENT. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER THE 3.0X12MM PROMUS ELEMENT MONORAIL WAS UNPACKED AND BEING FLUSHED DURING PREPARATION THE PHYSICIAN NOTICED THAT THE PROXIMAL AND DISTAL STRUTS OF THE STENT WERE PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY. AFTER THE 3.0X12MM PROMUS ELEMENT MONORAIL WAS UNPACKED AND BEING FLUSHED DURING PREPARATION THE PHYSICIAN NOTICED THAT THE PROXIMAL AND DISTAL STRUTS OF THE STENT WERE PARTIALLY INFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    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 H7493911312300 14057866

    Patients

    Seq Age Sex Outcome Treatment
    1