BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2863979 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07796
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 10, 2012
    Report Date
    November 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    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. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. 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. 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. IT SHOULD BE NOTED THAT THE XIENCE PRIME 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. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.5X38 RX XIENCE PRIME STENT DELIVERY SYSTEM REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. (B)(4) - EXCESSIVE FORCE. 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

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION AND 90% STENOSIS, PRE-DILATATION WAS PERFORMED. A 2.75X38 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS THE LESION DUE TO THE PATIENT'S ANATOMY, FORCE WAS APPLIED AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES OUTSIDE OF THE PATIENT'S ANATOMY. THE DISTAL PORTION OF THE 2.75X38 RX PRIME SDS WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY AND A 2.5X38 RX XIENCE PRIME SDS WAS ADVANCED AND THE SAME OCCURRED, COULD NOT CROSS THE LESION DUE TO THE PATIENT'S ANATOMY, FORCE WAS APPLIED AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES OUTSIDE OF THE PATIENT'S ANATOMY. THE DISTAL PORTION OF THE 2.5X38 RX XIENCE PRIME SDS WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY AND REPLACED WITH ANOTHER STENT AND THE RESULT WAS SATISFACTORY. THERE WAS NO 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
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1051841

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR