BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1790275 · Received August 6, 2010

    Report

    Report Number
    2024168-2010-01627
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED.INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    DEVICE ISSUE: BALLOON RUPTURE. TIME OF DEVICE ISSUE: DURING DEPLOYMENT. ADVERSE EVENT: NONE. IT WAS REPORTED THAT PREDILATATION WAS PERFORMED WITH A 2.5 X 15 MM NON-ABBOTT BALLOON CATHETER. THEN, THE PROMUS STENT DELIVERY SYSTEM (SDS) WAS INSERTED; HOWEVER, THE BALLOON DID NOT INFLATE. THE BALLOON BURST AS SOON AS AN ATTEMPT WAS MADE TO INFLATE. THE STENT DID NOT COME OFF OF THE BALLOON. THE STENT DID NOT APPEAR TO HAVE EXPANDED. NO KINKS OR DAMAGE TO THE DEVICE WAS NOTED. THE PROMUS WAS REMOVED AND A NON-ABBOTT DRUG ELUTING STENT WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0031661

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR GUIDE CATH: JR4| GUIDE WIRE: RUN THRU: INFLATION, MERIT,| DILATATION CATHETER: 2.5 X 15 MAVERICK,| STENT: TAXUS LIBERTE 2.75 X 20