BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2954984 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00765
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT KINK AND SEPARATION WERE CONFIRMED. DIFFICULT TO REMOVE FROM ROTATING HEMOSTATIC VALVE WAS NOT 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. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A DE NOVO LESION IN THE MID LEFT CIRCUMFLEX WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS, A 2.0X15 VOYAGER BALLOON CATHETER WAS ADVANCED TO THE LESION AND PRE-DILATATION WAS PERFORMED. THE 2.0X15 VOYAGER BALLOON CATHETER WAS WITHDRAWN AND A 2.25X28 RX XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE PATIENT ANATOMY EVEN AFTER SEVERAL ATTEMPTS. DURING WITHDRAWAL, THE SDS BECAME STUCK INSIDE OF THE HEMOSTATIC VALVE. REPORTEDLY, IN AN ATTEMPT TO PULL THE SDS, FORCE WAS APPLIED AND THE PROXIMAL PORTION OF THE SHAFT BECAME KINKED AND THEN SEPARATED CLOSE TO THE HUB. REPORTEDLY, THE DISTAL PORTION WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE. A NEW SAME SIZE RX XIENCE V SDS WAS ADVANCED AND SUCCESSFULLY CROSSED THE LESION. THE STENT WAS DEPLOYED AT 16 ATMOSPHERES TO ACHIEVE GOOD TIMI FLOW. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59114 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2071141

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR