BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 3052142 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02209
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    December 29, 2012
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS AND VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED STENT DAMAGE. THE STRUTS THROUGHOUT THE STENT WERE STRETCHED AND MISALIGNED AND THERE WERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE AND IN THE LUMEN. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS INFLATED WITH NO ISSUES NOTED. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE AND ALSO IN THE LUMEN. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. SAME CASE AS MDR#: 2134265-2013-02208. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE STENT DELIVERY BALLOON FAILED TO INFLATE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 80% DE NOVO, CONCENTRIC, 2.75X33MM TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX ARTERIES. THE LESION WAS PREDILATED WITH A 2.5X15 NON-BSC BALLOON CATHETER WHICH REDUCED THE STENOSIS TO 50%. A 2.75 X 38MM PROMUS ELEMENT MR STENT WAS ADVANCED TO THE LEFT ANTERIOR DESCENDING LESION; HOWEVER, THE PROMUS ELEMENT WAS UNABLE TO INFLATE. ANOTHER 2.75 X 38MM PROMUS ELEMENT MR STENT WAS ADVANCED TO THE TARGET LESION WHICH WAS ALSO UNABLE TO INFLATE. CONTRAST MEDIA AND RATIO IN THE INFLATION DEVICE WAS 75%. BOTH PROMUS ELEMENT STENT DEVICES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BRAND STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155430 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338270 0014561553

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR BALLOON CATH: SPRINTER 2.5 X 15| GUIDE WIRE: WHISPER| GUIDE CATHETER: 6FR XB 3.5