BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3812441 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02618
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    January 20, 2014
    Report Date
    April 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE DEVICE WAS RECEIVED FOR ANALYSIS IN THREE SECTIONS, AS A RESULT OF TWO BREAKS IN THE HYPOTUBE. THE FIRST BREAK WAS IDENTIFIED 8CM DISTAL TO THE STRAIN RELIEF. THE SECOND BREAK IN THE HYPOTUBE WAS IDENTIFIED 43CM PROXIMAL TO THE MIDSHAFT BOND. THE SECTION OF HYPOTUBE BETWEEN THE TWO BREAKS WAS MEASURED TO BE 54CM IN LENGTH. THE HYPOTUBE WAS SEVERELY KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. NO ISSUES WERE NOTED WITH THE CRIMPED STENT AND BALLOON. 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) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS UNKNOWN. THE LESION WAS PRE-DILATED WITH A 2.5X12MM NON BSC BALLOON. A 2.50X12MM PROMUS PREMIER STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. THE CATHETER WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291807 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952812250 16593547

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC SPRINTER 2.5X12