BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2830241 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-07048
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER:A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO ISSUES WITH THE DEVICE. THE CRIMPED STENT, BALLOON AND TIP 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION. PRE-DILATION WAS PERFORMED SUCCESSFULLY USING A 2.75X15MM NON-BSC BALLOON CATHETER. NEXT A 3.0X28MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT, BUT "WHILE ADVANCING THE STENT ACROSS THE LESION THE PHYSICIAN NOTICED DISLODGED THROMBUS AT THE DISTAL END OF THE STENT." THE PHYSICIAN DECIDED TO WITHDRAW THE 3.0X28MM PROMUS ELEMENT STENT AND USE A 3.0X32MM PROMUS ELEMENT STENT, SO AS TO COVER THE THROMBUS AT THE DISTAL END OF THE LESION. A 3.0X15MM NC QUANTUM APEX BALLOON WAS USED TO POST DILATE THE STENT COVERING THE ENTIRE LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NO VESSEL CALCIFICATION. PRE-DILATION WAS PERFORMED SUCCESSFULLY USING A 2.75X15MM NON-BSC BALLOON CATHETER. NEXT A 3.0X28MM PROMUS ELEMENT STENT WAS ADVANCED FOR TREATMENT, BUT "WHILE ADVANCING THE STENT ACROSS THE LESION THE PHYSICIAN NOTICED DISLODGED THROMBUS AT THE DISTAL END OF THE STENT". THE PHYSICIAN DECIDED TO WITHDRAW THE 3.0X28MM PROMUS ELEMENT STENT AND USE A 3.0X32MM PROMUS ELEMENT STENT, SO AS TO COVER THE THROMBUS AT THE DISTAL END OF THE LESION. A 3.0X15MM NC QUANTUM APEX BALLOON WAS USED TO POST DILATE THE STENT COVERING THE ENTIRE LESION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 15194625

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention BMW GUIDE WIRE| 2.75X15MM TAMARIND BALLOON CATHETER