BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

    MDR report key: 1220873 · Received October 29, 2008

    Report

    Report Number
    2024168-2008-01023
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 29, 2008
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THERE WAS BLOOD VISIBLE IN THE GUIDE WIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. AFTER PRESSURIZING THE BALLOON, A PINHOLE WAS OBSERVED IN THE DISTAL SHOULDER. THERE WAS A 1 MM SCRATCH IN THE DISTAL TAPER NEAR THE PINHOLE. THERE WERE THREE KINKS IN THE SHAFT 8.6 CM, 9.8 CM AND 12.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO COMPLETE THE EVALUATION OF THE EVENT AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE RIGHT CORONARY ARTERY DURING THE FIRST INFLATION AT 14 ATM. AS SOON AS THE BALLOON HIT 14 ATM, IT STARTED LEAKING. THE STENT WAS DEPLOYED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. 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 SYSTEMS NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8022061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK