BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3790529 · Received May 5, 2014

    Report

    Report Number
    2134265-2014-02468
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. IT WAS NOTED THAT THE STENT STRUTS ON THE SIXTH ROW FROM THE PROXIMAL END WERE LIFTED AND DEFORMED. THE OD OF THE ANALYSED CRIMPED STENT WAS MEASURED WITH A SNAPGAUGE. THE INNER DIAMETER (ID) OF THE STENT PROTECTOR USED WAS BASED ON A REVIEW OF DOCUMENTATION ASSOCIATED WITH THE MANUFACTURE OF FINISHED GOODS BATCH (FGB). THIS INDICATES THAT THE STENT WAS DAMAGED MOST LIKELY DURING PREPARATION OF THIS DEVICE WHEN THE PHYSICIAN USED A ¿WET GAUZE PAD¿ ON THE STENT. THIS ALSO WOULD INDICATE THE PROBABLE REASON FOR MATERIAL FABRIC BEEN CAUGHT ON THE STENT STRUTS FOLLOWING INSPECTION. A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE TIP OF THE DEVICE WAS DAMAGED AND THE HYPOTUBE WAS KINKED AT MULTIPLE LOCATIONS ALONG ITS LENGTH. THE BALLOON WAS VISUALLY AND MICROSCOPICALLY EXAMINED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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. A 4.00MM X 20MM PROMUS ELEMENT PLUS STENT WAS SELECTED. DURING THE PREPARATION, IT WAS NOTICED THAT A STENT STRUT BROKE AND WAS STICKING OUT. THIS WAS NOTED WHEN A WET GAUZE PAD WAS RAN DOWN THE LENGTH OF THE STENT AND A PIECE OF THE GAUZE WAS CAUGHT ON THE STRUT. THE DEVICE WAS NEVER USED IN THE PATIENT. THE PROCEDURE WENT WELL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00MM X 20MM PROMUS ELEMENT PLUS STENT WAS SELECTED. DURING THE PREPARATION, IT WAS NOTICED THAT A STENT STRUT BROKE AND WAS STICKING OUT. THIS WAS NOTED WHEN A WET GAUZE PAD WAS RAN DOWN THE LENGTH OF THE STENT AND A PIECE OF THE GAUZE WAS CAUGHT ON THE STRUT. THE DEVICE WAS NEVER USED IN THE PATIENT. THE PROCEDURE WENT WELL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268406 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420400 0016455736

    Patients

    Seq Age Sex Outcome Treatment
    1