BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2863008 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07470
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME PATIENT THAN MDR# 2134265-2012-07471. IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION, DISSECTION AND STENT DAMAGE OCCURRED. THE LESION WAS SITUATED IN THE RCA (RIGHT CORONARY ARTERY). A GUIDE CATHETER 6F WAS ENGAGED AND A WIRE WAS PLACED INTO THE RIGHT POSTEROLATERAL ARTERY (PLA). A 3.5 X 28 MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE MID RCA. AFTER DIFFERENT VIEW OF THE RCA, A NARROWING WAS NOTED AT THE ORIGIN OF THE PDA (POSTERIOR DESCENDING ARTERY). AN 8F GUIDE CATHETER WAS INTRODUCED; THE LESION WAS PRE-DILATED WITH A NON-BSC BALLOON. A 2.25 X 20 MM PROMUS ELEMENT PLUS STENT WAS PLACED INTO THE PDA WITH GOOD RESULT. A 2.75 X 32 MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED INTO THE RCA AND INTO THE PLA. THE PROXIMAL PART OF THE STENT WAS POSTDILATED WITH A NON-BSC BALLOON AND A SIGNIFICANT DISSECTION WAS NOTICED DISTAL TO THE STENT. A DISRUPTION WAS THEN NOTICED AT THE PROXIMAL PART OF THE STENT AFTER AN UNSUCCESSFUL ATTEMPT TO PASS A 2.5 X 20 MM PROMUS ELEMENT PLUS STENT. THE PROXIMAL PART OF THE STENT WAS POST-DILATED WITH THE AID OF A GUIDE LINER BUT IT WAS NOT POSSIBLE TO CROSS WITH A STENT. A NARROWING AT THE ORIGIN OF THE RCA WAS THEN NOTICED, AND A 3.5 X 16 MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED. THE PHYSICIAN CONTINUED TO ATTEMPT TO GET A STENT INTO THE DISTAL PLA, BUT WAS UNABLE TO. A LONGITUDINAL STENT DEFORMATION WAS THEN NOTICED AT THE PROXIMAL END OF THE 3.5 X 16 MM STENT. THE PATIENT REMAINED STABLE AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432270

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention 2.0 X 10 MM SPRINTER BALLOON (MEDTRONIC)| 3.5 X 28 MM PROMUS ELEMENT PLUS STENT| 2.25 X 20 MM PROMUS ELEMENT PLUS STENT