BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ? LONG

    MDR report key: 3173468 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-04198
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: INITIAL VISUAL EXAMINATION NOTED THE PRESENCE OF DISTAL STENT STRUT DAMAGE AS THE PROFILE OF SOME OF THE DISTAL STRUTS WERE STRETCHED DISTALLY TOWARDS THE TIP OF THE DEVICE. THE 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. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED CIRCUMFLEX (CX). THIS 3.00X38MM PROMUS ELEMENT STENT WAS SELECTED; HOWEVER, DURING INTRODUCTION INTO THE NON-BSC GUIDE CATHETER THE STENT TOUCHED THE NON-BSC GUIDE WIRE INSIDE THE GUIDE CATHETER AND BECAME DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED CIRCUMFLEX (CX). THIS 3.00X38MM PROMUS ELEMENT STENT WAS SELECTED; HOWEVER, DURING INTRODUCTION INTO THE NON-BSC GUIDE CATHETER THE STENT TOUCHED THE NON-BSC GUIDE WIRE INSIDE THE GUIDE CATHETER AND BECAME DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273481 PROMUS ELEMENT ? LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338300 15093365

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: WHISPER| GUIDE CATHETER: ZUMA 6F MEDTRONIC