BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3073178 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02536
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT REMAINED CRIMPED ON THE BALLOON BUT BOTH THE DISTAL AND PROXIMAL EDGE OF THE STENT WERE FLARED OUTWARDLY. THE BALLOON APPEARED TO HAVE BEEN PARTIALLY INFLATED AT BOTH SIDES. THE PROXIMAL EDGE OF THE STENT ALSO HAD SOME STENT DAMAGE AS A NUMBER OF STRUTS WERE BENT BACK DISTALLY. THERE WERE TRACES OF SOLIDIFIED CONTRAST MEDIA INSIDE THE BALLOON AND INSIDE THE LUMEN. THREE ATTEMPTS WERE MADE TO INFLATE THE BALLOON BUT ALL ATTEMPTS WERE UNSUCCESSFUL, DUE TO THE CONSIDERABLE QUANTITY OF SOLIDIFIED CONTRAST MEDIA INSIDE THE LUMEN. THE DEVICE WAS THEN SOAKED IN A WATER BATH AND ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON AND IT INFLATED WITH NO ISSUES NOTED. NO FURTHER DAMAGE WAS NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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 DEVICE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX). A 2.50X16MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LCX; HOWEVER, THE STENT DELIVERY BALLOON WAS UNABLE TO INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175605 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416250 0015206014

    Patients

    Seq Age Sex Outcome Treatment
    1