BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2822910 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-06736
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THERE WAS CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE STENT WAS NOT RECEIVED FOR ANALYSIS. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS, WHICH INDICATES THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) OF 18 ATM WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED LESION. A 3 X 8 MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED AT 16 ATMS FOR 30 SECONDS. WHEN THE PHYSICIAN RE-INFLATED THE STENT DELIVERY BALLOON, THE BALLOON RUPTURED AT 13 OR 14 ATMS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 3.0 X 15 MM APEX BALLOON, WHICH WAS INFLATED AT 14 ATMS FOR 15 SECONDS. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENT'S CONDITION IS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED LESION. A 3X8MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED AT 16ATMS FOR 30 SECONDS. WHEN THE PHYSICIAN RE-INFLATED THE STENT DELIVERY BALLOON, THE BALLOON RUPTURED AT 13 OR 14 ATMS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 3.0X15MM APEX BALLOON, WHICH WAS INFLATED AT 14ATMS FOR 15 SECONDS. NO PATIENT COMPLICATIONS WERE NOTED AND THE PATIENTS CONDITION IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911608300 14987604

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR