BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1980666 · Received February 7, 2011

    Report

    Report Number
    2024168-2011-00730
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STENT: XIENCE V 3.0 X 18 MM (PART#1009541-18/LOT#0072741/SERIAL#(B)(4)); MINI VISION 2.5 X 15 MM (PART#1007823-15/LOT#0042241). THE XIENCE V 3.0 X 18 MM (PART#1009541-18/LOT#0072741/SERIAL#(B)(4)), MINI VISION 2.5 X 15 MM (PART#1007823-15/LOT#0042241), AND VOYAGER NC 5.0 X 12 MM (PART#1011760-12/LOT# UNKNOWN), ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. 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 IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE PATIENT ANATOMY WAS HEAVILY CALCIFIED AND THE STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH A PREVIOUSLY IMPLANTED STENT WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT WAS REPORTED THE PHYSICIAN WAS CONCERNED THAT THE THREE SDS THAT FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENT MAY HAVE CAUSED DAMAGE TO THE STENT, WHICH WAS POST DILATED WITH A VOYAGER NC BALLOON. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTIES INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE GUIDE CATHETER WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, DAMAGE TO THE STENT OR TO THE GUIDE CATHETER. THERE WAS NO NOTE OF ANY DAMAGE TO THE SDS OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. RETURN OF THE XIENCE V SDS MAY HAVE AIDED IN THE INVESTIGATION. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE CAUSE FOR THE REPORTED DEVICE DAMAGING ANOTHER DEVICE COULD NOT BE DETERMINED HOWEVER, THE FAILURE TO ADVANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL SDS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL SDS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0 X 18 MM XIENCE, 3.0 X 15 MM XIENCE AND 2.5 X 15 MM MINI VISION FAILED TO CROSS A PREVIOUSLY IMPLANTED STENT (UNKNOWN TYPE) TO TREAT A LESION LOCATED IN THE PROXIMAL CIRCUMFLEX. A 5.0 X 12 MM VOYAGER NC WAS THEN UTILIZED FOR POST DILATATION OF THE PREVIOUSLY IMPLANTED STENT BECAUSE THERE WAS SOME CONCERN BY THE PHYSICIAN THAT THE THREE DEVICES WHICH FAILED TO CROSS MAY HAVE CAUSED SOME DAMAGE, ALTHOUGH NO DAMAGE WAS VISUALIZED ON ANGIO. THE POST-DILATATION OF THE EXISTING PREVIOUSLY PLACED STENT IN THE LEFT MAIN CORONARY ARTERY WAS DONE FOR PRECAUTIONARY REASONS. UPON WITHDRAWAL, THERE WAS SOME RESISTANCE NOTED BETWEEN THE BALLOON DILATATION CATHETER AND A NON-ABBOTT GUIDING CATHETER. THE EVENT CAUSED A DELAY IN THE PROCEDURE, HOWEVER, IT WAS NOT CONSIDERED A CLINICALLY SIGNIFICANT DELAY. NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0063041

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention