BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2961568 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00679
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DETACHED FROM THE BALLOON. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE STENT WAS NOT RETURNED FOR ANALYSIS. KINKS WERE NOTICED ALONG THE SHAFT 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE GUIDEWIRE LUMEN, THEREFORE, INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 CORONARY STENTING TREATMENT PROCEDURE, THE STENT DISLODGED. THE >80% STENOSED TARGET LESION WAS LOCATED IN A VERY CALCIFIED SAPHENOUS VEIN GRAFT AT THE OBTUSE MARGINAL ARTERY. A 4.00X16MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE STENT BECAME STUCK ON A CALCIUM PRIOR TO REACHING THE TARGET LESION AND DISLODGED INSIDE THE PATIENT. THE STENT WAS SNARED OUT AND THE LESION WAS TREATED WITH A 4.0X12MM EMERGE BALLOON CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DISLODGED. THE >80% STENOSED TARGET LESION WAS LOCATED IN A VERY CALCIFIED SAPHENOUS VEIN GRAFT AT THE OBTUSE MARGINAL ARTERY. A 4.00X16MM PROMUS ELEMENT PLUS DRUG ELUTING STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION; HOWEVER, THE STENT BECAME STUCK ON A CALCIUM PRIOR TO REACHING THE TARGET LESION AND DISLODGED INSIDE THE PATIENT. THE STENT WAS SNARED OUT AND THE LESION WAS TREATED WITH A 4.0X12MM EMERGE BALLOON CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64183 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416400 0015526358

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention