BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202767 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04642
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED WITHOUT A STENT AND WITHOUT THE PRODUCT MANDREL. THE STENT PROTECTOR WAS PLACED OVER THE BALLOON. THE BALLOON DID NOT APPEAR TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE, AND THE STENT CRIMP MARKS WERE CLEARLY VISIBLE ON THE BALLOON MATERIAL. THE BALLOON WAS FOLDED. THERE WAS NO VISIBLE DAMAGE ALONG THE LENGTH OF THE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, A STENT WAS DISLODGED FROM A BALLOON. DURING UNPACKING, THEY NOTICED THAT THE 4.00X 16MM PROMUS ELEMENT PLUS STENT WAS LOOSE FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE NOTED AND PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, A STENT WAS DISLODGED FROM A BALLOON. DURING UNPACKING, THEY NOTICED THAT THE 4.00X 16MM PROMUS ELEMENT PLUS STENT WAS LOOSE FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE NOTED AND PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303035 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416400 15867273

    Patients

    Seq Age Sex Outcome Treatment
    1