BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1358272 · Received March 13, 2009

    Report

    Report Number
    2024168-2009-00414
    Event Type
    Malfunction
    Date Received
    March 13, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 17, 2009
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS. THERE WAS NO DAMAGE REPORTED AFTER REMOVAL OF THE DEVICE FROM PACKAGING. TO HELP ENSURE THESE TYPES OF EVENTS ARE NOT THE RESULT OF MANUFACTURING, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE, AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, PRIOR TO LOT RELEASE, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. THEREFORE, THIS COMPLAINT DOES NOT APPEAR TO BE RELATED TO A SDS QUALITY DEFICIENCY; HOWEVER, BASED ON THE REPORTED INFORMATION A CONCLUSIVE CAUSE FOR THE REPORTED DISLODGEMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PATIENT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT FELL OFF THE STENT DELIVERY SYSTEM (SDS) DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT. 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 SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK