BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1870020 · Received October 15, 2010

    Report

    Report Number
    2134265-2010-04486
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    June 29, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT: DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MID ANTERIOR INTERVENTRICULAR ARTERY (AIV). THE OSTIUM OF THE SECOND DIAGONAL BRANCH WAS PREDILATED WITH A 2.0X9 MAVERICK2 BALLOON, INFLATED TWICE TO 15 ATM FOR 65 SECONDS. A 2.5X30MM MAVERICK BALLOON WAS USED TO PREDILATE THE "AIV 2", INFLATED ONCE TO 18 ATM FOR 40 SECONDS. THEN A 2.5X24MM PROMUS ELEMENT STENT WAS POSITIONED IN THE MID AIV TO TREAT THE DISTAL LESION. THE PHYSICIAN HAD EXPERIENCED SOME DIFFICULTIES CROSSING THE LESION, BUT WAS ABLE TO DEPLOY THE STENT, INFLATED TWICE TO 14 ATM FOR 50 SECONDS. A SECOND 3.0X38MM PROMUS ELEMENT STENT, WAS POSITIONED IN THE MID AVI. THE PHYSICIAN HAD EXPERIENCED SOME DIFFICULTIES CROSSING THE LESION, BUT WAS ABLE TO DEPLOY THE STENT, INFLATED TWICE TO 18 ATM FOR 40 SECONDS. THE FINAL STENT PLACED WAS A 2.5X8MM PROMUS STENT POSITIONED IN THE MID AVI, NOT OVERLAPPING THE TWO PREVIOUSLY PLACED STENTS, INFLATED TO 20 ATM FOR 40 SECONDS. TO ENSURE A FULL DEPLOYMENT OF THE THREE STENTS, A 3.0X15MM NON-BSC BALLOON WAS POSITIONED DOWNSTREAM FROM THE MID AVI AND INFLATED FOUR TIMES TO A MAXIUM PRESSURE OF 24 ATM FOR 150 SECONDES. A ¿KISSING-BALLOON¿ WAS THEN PERFORMED WITH A 2.0X15MM MAVERICK BALLOON POSITIONED IN THE OSTIUM OF THE FIRST DIAGONAL BRANCH, INFLATED TO 18 ATM FOR 45 SECONDS, AND A 3.0X15MM NON-BSC BALLOON POSITIONED IN THE MID AVI, INFLATED TO 18 ATM FOR 30 SECONDS. THE FINAL ANGIOGRAM SHOWED THE MID AVI HAD NO SIGNIFICANT LESION, VISIBLE DISSECTION, OR THROMBUS. THE CORONARY BLOOD FLOW WAS TIMI 3. THE PATIENT DID NOT HAVE ANY SPASMS DURING THE PROCEDURE. A NON SIGNIFICATIVE LESION, LESS THEN 50%, WAS IDENTIFIED IN THE OSTIUM OF THE FIRST DIAGONAL BRANCH. THE PHYSICIAN IDENTIFIED THE 2.5X24MM PROMUS ELEMENT STENT WAS "COMPACTED WITH AN ASPECT OF ACCORDIAN. IT'S SIZE WAS REDUCED." NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS REPORTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324250 13407771

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 2X15MM MAVERICK BALLOON| A BMW 0.014 GUIDE WIRE| 2.5X30MM MAVERICK BALLOON| 3.0X15MM HIRIYU BALLOON| VISA BRITE TIP XB 3.5 6F GUIDING CATHETER| A CRUISER HYDRO ES-F GUIDE WIRE| 2.0X9 MAVERICK2 BALLOON| 2.5X8MM PROMUS STENT| 3.0X38MM PROMUS ELEMENT STENT| 3.0X15MM HIRIYU BALLOON