BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3133310 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03338
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT BEND/KINK WAS NOT CONFIRMED. DIFFICULT TO POSITION/DIFFICULT TO REMOVE (GUIDE WIRE RESISTANCE) WERE NOT CONFIRMED. SHAFT TEAR AND SHAFT SEPARATION WERE CONFIRMED. BASED ON VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDE WIRE: HI-TORQUE WHISPER MS 190CM; BALANCE MIDDLEWEIGHT; GUIDE CATH: GUIDELINER. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE HI-TORQUE BALANCE MIDDLEWEIGHT AND HI-TORQUE WHISPER REFERENCED ARE BEING FILED UNDER SEPARATE MANUFACTURING REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY TORTUOUS, THROMBOTIC, HEAVILY CALCIFIED, 100% STENOSED, PROXIMAL AND MID PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED FOR ACCESS AND PREDILATATION WITH A 3.0 X 8 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC). A 3.5 X 18 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION AND WAS REMOVED WITHOUT ISSUE. A WHISPER BUDDY WIRE WAS INTRODUCED AND THE LESION WAS ATTEMPTED WITH A 3.5 X 12 MM XIENCE PRIME SDS, HOWEVER, THE HYPOTUBE BECAME KINKED AND THE SDS WAS REMOVED FROM THE ANATOMY. A SECOND 3.5 X 12 MM XIENCE PRIME SDS WAS DELIVERED, HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE BMW GUIDE WIRE AND SDS APPEARED TO BE MOVING TOGETHER AS A SYSTEM; EVERYTHING WAS REMOVED TOGETHER AND DURING THE REMOVAL THE PROXIMAL SHAFT BENT AND OUTSIDE THE ANATOMY BECAME SEPARATED. DURING INSPECTION THE SDS HYPOTUBE WAS NOTED TO HAVE SEVERAL PUNCTURES IN THE DISTAL SEGMENT AND A PORTION OF WIRE PROTRUDING FROM ONE OF THE PUNCTURES. THE DEVICES WERE NOT USED. A SECOND WHISPER GUIDE WIRE WAS USED AND A 2.75 X 18 MM NON-ABBOTT SDS WAS ADVANCED BUT WAS UNSUCCESSFUL IN CROSSING THE LESION. A 2.75 X 14 MM NON-ABBOTT SDS WAS DELIVERED AND DEPLOYED IN THE LESION; POST DILATED TO 3.5 MM USING A 3.5 X 12 MM NON-ABBOTT BDC. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234861 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2081341

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR