BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1935994 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02860
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DILATATION CATHETER: 2.5 X 12 MM MAVERICK; GUIDE WIRE: KINETIX, CHOICE PT; STENT: 2.75 X 12 MM VERIFLEX. THE STENT REMAINS IN THE PATIENT. THE STENT DELIVERY SYSTEM WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE ANATOMICAL CONDITION WAS NOT REPORTED, THE FAILURE TO ADVANCE IS NOT GENERALLY ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY AND WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. DISSECTION, AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND PRODUCT SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED DISSECTION, THE FAILURE TO CROSS AND ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WENT IN WITH A NON-ABBOTT GUIDE WIRE AND ENDED UP BALLOONING WITH A NON-ABBOTT 2.5 X 12 BALLOON DILATATION CATHETER, DEFLATED THE BALLOON AND THEN TRIED TO GO IN WITH THE PROMUS. THE PROMUS DID NOT CROSS SO THEY PULLED THE STENT BACK AND NOTICED A DISSECTION. THEY THEN WENT DOWN WITH A NON-ABBOTT GUIDE WIRE INTO THE CIRCUMFLEX FOR SUPPORT, BUT IT DID NOT WORK AND THEY HAD TO REMOVE EVERYTHING. THEY WENT BACK IN AND PLACED A NON-ABBOTT 2.75 X 12 MM STENT OVER THE LESION SUCCESSFULLY WITH NO HARM TO THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention