BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2770944 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06026
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: ONLY THE STENT WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT FOUND THE STENT WAS SEVERELY STRETCHED ALONG ITS LENGTH. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE AND DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.5 X 24MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A JR NON BSC GUIDE CATHETER, BUT AFTER SEVERAL ATTEMPTS, WAS UNABLE TO CROSS THE LESION. WHEN THE SDS WAS "FORCEDLY" REMOVED FROM THE PATIENT IT WAS NOTED THAT THE STENT HAD STRETCHED, AND DISLODGED INSIDE THE VESSEL AT THE DISTAL END OF THE GUIDE CATHETER. THE STENT WAS RETRIEVED AND REMOVED TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 23MM NON BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE AND DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 3.5 X 24MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A JR NON BSC GUIDE CATHETER, BUT AFTER SEVERAL ATTEMPTS, WAS UNABLE TO CROSS THE LESION. WHEN THE SDS WAS "FORCEDLY" REMOVED FROM THE PATIENT IT WAS NOTED THAT THE STENT HAD STRETCHED, AND DISLODGED INSIDE THE VESSEL AT THE DISTAL END OF THE GUIDE CATHETER. THE STENT WAS RETRIEVED AND REMOVED TOGETHER WITH THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A 3.5 X 23MM NON BSC STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324350 14997893

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH LESS JR: GUIDE CATHETER