BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 18979169 · Received March 26, 2024

    Report

    Report Number
    2024168-2024-03659
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 5, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648295560
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 CORRECTION: LOT # UPDATED FROM 3041141 TO 3112341. A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS. A CONCLUSIVE CAUSE FOR THE REPORTED DISLODGEMENT COULD NOT BE DETERMINED. STENT DISLODGEMENT PRIOR TO USE MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION, AND INTERACTION WITH ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THAT INADVERTENT MISHANDLING DURING UNPACKAGING/PREPARATION OF THE DEVICE (SHEATH/STYLET REMOVAL) MAY HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT; HOWEVER, BASED ON THE INFORMATION RECEIVED AND ANALYSIS OF THE RETURNED DEVICE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE 3.5X28 MM XIENCE PROS STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PACKAGING, THE STENT SLIPPED OFF OF THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW XIENCE PROS SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13417 XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 3112341 08717648295560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown