BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6977700 · Received October 25, 2017

    Report

    Report Number
    2024168-2017-08470
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 19, 2017
    Report Date
    January 16, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4). CORRECTION LOT# 6092341. (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED. 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 INVESTIGATION DETERMINED THE REPORTED/NOTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THAT AS THE DEVICE WAS ADVANCED OVER THE GUIDE WIRE INADVERTENT MISHANDLING RESULTED IN THE NOTED STRETCHED INNER/OUTER MEMBER (THUS RESULTING IN THE NOTED CRIMP MARKS LOCATED 2MM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKER), THE NOTED STENT DAMAGE (STRETCHED) ULTIMATELY RESULTED IN THE REPORTED STENT DISLODGEMENT. THE NOTED BENT TIP LIKELY OCCURRED DUE TO HANDLING OR DURING PACKING FOR RETURN ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, DURING MANIPULATION OF THE 2.5X23 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) THE STENT DISLODGED FROM THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED STENT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE ADDITIONAL INFORMATION WAS RECEIVED SUBSEQUENT TO MEDWATCH: THE STENT DISLODGED WHILE ADVANCING THE SDS ON THE GUIDE WIRE, BEFORE ENTERING THE GUIDE CATHETER, "Y" CONNECTOR. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755044 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6092341

    Patients

    Seq Age Sex Outcome Treatment
    1