BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2982957 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-00987
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: IT WAS INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER. THE INVESTIGATION INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 34X2.5MM, 95% STENOSED, CONCENTRIC, DE NOVO LESION BEING TREATED WAS LOCATED IN THE HEAVILY CALCIFIED, NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. . THE PHYSICIAN PERFORMED ROTATIONAL ATHERECTOMY WITH 1.25 BURR AND ABLATED 4 TIMES WITH THE RPM OF 1.8L. THEN THE PHYSICIAN USED A 2.5X10 NON-BSC BALLOON AND PREDILATED THE TARGET LESION AT 16ATMS AND A 2.5X38MM PROMUS ELEMENT STENT WAS IMPLANTED. THEN WHILE POSTDILATING WITH AN UNKNOWN BALLOON, THE BALLOON CAUGHT THE PROXIMAL EDGE OF THE STENT CAUSING IT TO DEFORM. THE PROCEDURE WAS COMPLETED BY IMPLANTING A 2.75X12 NON-BSC STENT AT THE PROXIMAL EDGE OF THE DEFORMED STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85884 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 0015398989

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention ROTABLATOR ABALATION SYSTEM| 2.5X15MM ACROSS HP BALLOON CATHETER| 7F XB3 GUIDE CATHETER| BMW GUDE WIRE| 2.5X10MM ACROSS HP BALLOON CATHETER