BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2983477 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01112
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS RETURNED. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT REVEALED THAT ONE END OF THE STENT WAS DAMAGED/FLATTENED. SOME STRUTS WERE ALSO RAISED UP. A KINK WAS NOTED IN THE HYPOTUBE 580MM DISTAL TO THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 FURTHER REPORTED THAT THERE WAS STRONG RESISTANCE ENCOUNTERED UPON ADVANCING THE SDS. THE SDS AND GUIDE CATHETER WERE REMOVED TOGETHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). A 2.5 X 38MM PROMUS ELEMENT STENT WAS DEPLOYED FROM THE MID TO DISTAL RCA. THE 3.5 X 20MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM WAS ADVANCED, BUT IT WAS NOTED THAT THE STENT HAD DETACHED INSIDE THE 6FR. NON BSC GUIDE CATHETER. THE PHYSICIAN ALSO USED A NON BSC CHILD-SIZED CATHETER, WHICH HE/SHE THOUGHT HAD COME IN CONTACT WITH THE STENT WHEN IT DETACHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86285 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15135568

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention