BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6767558 · Received August 4, 2017

    Report

    Report Number
    2024168-2017-06422
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    July 7, 2017
    Report Date
    August 23, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - 326052/1-2. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEVICE MISASSEMBLED DURING MANUFACTURING OR SHIPPING/MARKER BAND MISLOCATION WAS UNABLE TO BE CONFIRMED. THE REPORTED DIFFICULT TO POSITION WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED DEVICE MISASSEMBLED DURING MANUFACTURING OR SHIPPING/MARKER BAND MISLOCATION WAS UNABLE TO BE CONFIRMED AS BOTH BALLOON MARKER BAND LOCATIONS WERE WITHIN MANUFACTURING SPECIFICATIONS, AND THE INVESTIGATION DETERMINED THE REPORTED DIFFICULT TO POSITION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT THE LOCATION OF THE PROXIMAL BALLOON MARKER BAND WITHIN THE BALLOON WORKING LENGTH CONTRIBUTED TO THE REPORTED STENT IMPLANTED NOT FULLY IN THE LESION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    ADDITIONALLY, IT WAS REPORTED THAT NO INTERVENTION WAS PERFORMED AND THE PATIENT OUTCOME WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MODERATELY CALCIFIED, DIAGONAL ARTERY OSTIUM LESION, THE XIENCE ALPINE STENT WAS IMPLANTED, NOT FULLY IN THE LESION, BECAUSE THE BALLOON MARKER WAS MISLOCATED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546662 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5102141

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR