BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3931282 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04149
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    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 IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND PROXIMAL STENT DAMAGE WHEREBY THE PROXIMAL STENT STRUTS WERE BUNCHED UP DISTALLY. THESE DAMAGED STRUTS WERE JUST DISTAL TO THE STENT PROTECTOR THAT HAD BEEN RETRACTED PROXIMALLY OVER THE STENT. A VISUAL EXAMINATION OF THE TIP FOUND NO ISSUES WITH ITS PROFILE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. A VISUAL AND TACTILE EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. DURING ANALYSIS IT WAS NOT POSSIBLE TO MOVE THE STENT PROTECTOR DISTALLY OVER THE STENT DUE TO THE STENT DAMAGE. WHEN THE STENT PROTECTOR WAS FORCED OVER THE STENT, IT DAMAGED THE STENT FURTHER. THE MAXIMUM CRIMPED STENT PROFILE AND THE ID OF THE RETURNED STENT PROTECTOR WERE MEASURED AND WERE WITHIN SPECIFICATION. IT CAN BE THEREFORE CONCLUDED THAT THE STENT PROTECTOR WAS NOT TOO TIGHT ON THE CRIMPED STENT AND THE DAMAGE MOST LIKELY OCCURRED DURING REMOVAL OF THE STENT PROTECTOR. 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 80% RESTENOSED 3.5X12 MM, ECCENTRIC TARGET LESION CONTAINED A LESION BEND OF <=45 DEGREES AND WAS LOCATED IN A NON TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). AFTER INTRODUCTION OF A NON-BSC GUIDE CATHETER AND A PT2 GUIDEWIRE, PREDILATION WAS PERFORMED WITH A 3.5/5 UNSPECIFIED CATHETER BALLOON. A 3.50X12MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 80% RESTENOSED 3.5X12 MM, ECCENTRIC TARGET LESION CONTAINED A LESION BEND OF <=45 DEGREES AND WAS LOCATED IN A NON TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). AFTER INTRODUCTION OF A NON-BSC GUIDE CATHETER AND A PT2 GUIDEWIRE, PREDILATION WAS PERFORMED WITH A 3.5/5 UNSPECIFIED CATHETER BALLOON. A 3.50X12MM PROMUS ELEMENT DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE LESION. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED. THE PROCEDURE WAS COMPLETED A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411183 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 15872294

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR CATHETER BALLOON: 3.5/5| GUIDEWIRE: PT2| GUIDE CATHETER: 6F/JR4