BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2854865 · Received December 3, 2012

    Report

    Report Number
    2134265-2012-07275
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED INSIDE A CORDIS GUIDE CATHETER WITH THE STENT DISLODGED 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 DEVICE WAS REMOVED FROM THE GUIDE CATHETER AND THE STENT FELL OUT FROM THE GUIDE CATHETER. ONE END OF THE STENT WAS BUNCHED AND SEVERELY DAMAGED WITH SOME STRUTS FLATTENED AND RAISED UP. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE HAD KINKED APPROXIMATELY AT 50MM AND 885 DISTAL FROM THE CATHETER'S STRAIN RELIEF. A FURTHER KINK WAS ALSO NOTED 100MM PROXIMAL TO THE EXIT PORT. SEVERAL SMALLER KINKS WERE ALSO IDENTIFIED ALONG THE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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 PREPARATION FOR A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ADVANCED A 3.50X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) TO THE TARGET LESION. HOWEVER IT WAS UNABLE TO CROSS. UPON REMOVAL THE SDS BECAME STUCK INSIDE OF AN UNKNOWN GUIDE CATHETER AND THE STENT DISLODGED. THE STENT REMAINED INSIDE OF THE GUIDE CATHETER. THE DEVICES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 15134797

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention