BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3120838 · Received May 20, 2013

    Report

    Report Number
    2134265-2013-03422
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 24.4CM DISTAL TO THE STRAIN RELIEF. BOTH SECTIONS OF THE HYPOTUBE BREAK WERE KINKED. NO ISSUES WERE NOTED WITH THE PROFILES OF THE CRIMPED STENT BALLOON AND TIP. 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A CATHETER SHAFT FRACTURE OCCURRED. THE LESION WAS LOCATED AT THE RIGHT CORONARY ARTERY. A 2.75X16MM PROMUS ELEMENT DRUG ELUTING STENT WAS ADVANCED AND BREAKS ON THE SHAFT WERE NOTICED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A CATHETER SHAFT FRACTURE OCCURRED.THE LESION WAS LOCATED AT THE RIGHT CORONARY ARTERY. A 2.75X16MM PROMUS ELEMENT DRUG ELUTING STENT WAS ADVANCED AND BREAKS ON THE SHAFT WERE NOTICED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222811 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316270 15752614

    Patients

    Seq Age Sex Outcome Treatment
    1