BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2950106 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00735
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 15, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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. 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. (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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE PHYSICIAN WAS NOT ATTEMPTING TO ADVANCE THE XIENCE STENT SYSTEM THROUGH THE PREVIOUSLY IMPLANTED XIENCE STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE A 3.0X28 RX XIENCE STENT WAS IMPLANTED FROM THE LEFT MAIN TO THE LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED IN THE MILDLY CALCIFIED/TORTUOUS MID LEFT CIRCUMFLEX ARTERY USING A 2.5X15 NON-COMPLIANT UNSPECIFIED BALLOON AT 10 ATMOSPHERES IN PREPARATION OF STENTING A 70% STENOSIS. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE A 3.0X23 RX XIENCE V STENT SYSTEM; HOWEVER, THE STENT SYSTEM COULD NOT ADVANCE POSSIBLY DUE TO THE CHARACTERISTICS OF THE VESSEL, AND THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE ANATOMY. THE DISTAL SEGMENT OF THE STENT DELIVERY SYSTEM WAS SIMPLY WITHDRAWN FROM THE ANATOMY AND THE PROCEDURE WAS ABORTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PATIENT WILL BE MEDICALLY MANAGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54169 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072041

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR STENT: XIENCE V 3.0 X 28