BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10751914 · Received October 28, 2020

    Report

    Report Number
    2024168-2020-09007
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 13, 2020
    Report Date
    February 2, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. MISSING COMPONENTS MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING/PACKAGING OF THE DEVICE, TRANSPORT OF THE DEVICE, HANDLING AT THE ACCOUNT, INADVERTENT MISHANDLING DURING PREPARATION OR DURING THE PROCEDURE. FACTORS THAT COULD CONTRIBUTE TO PRODUCT QUALITY PROBLEMS INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INTERACTION WITH ACCESSORY DEVICES OR INADVERTENT MISHANDLING DURING UNPACKAGING/PREPARATION OF THE DEVICE. IN THIS CASE, IT IS POSSIBLE THAT THE STENT MAY HAVE DISLODGED INSIDE THE PROTECTIVE SHEATH DURING SHEATH/STYLET REMOVAL WHICH RESULTED IN THE REPORTED COMPONENT MISSING (STENT). IT IS ALSO POSSIBLE THE REPORTED PRODUCT QUALITY PROBLEM (LINES ON THE BALLOON) MAY HAVE BEEN RESIDUAL CRIMP MARKS FROM WHEN THE STENT WAS INITIALLY CRIMPED ON THE BALLOON DURING MANUFACTURING; HOWEVER, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE DEVICE TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. D4: PART NUMBER CHANGED FROM 1128350-23 TO 1128350-38. D4: LOT NUMBER CHANGED FROM 0030961 TO 0010241. D9, H3 - DEVICE STATUS CHANGED FROM YES TO NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER UNPACKING A 3.5X23MM XIENCE PROA, IT WAS NOTED THAT THE STENT WAS MISSING AND THE BALLOON WAS DAMAGED (LOOKED LIKE LINES ON BALLOON). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT, THEREFORE ANOTHER DRUG-ELUTING DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATES THAT THE CORRECT SIZE OF THE COMPLAINT DEVICE IS A 3.5X38MM XIENCE PROA AND NOT A 3.5X23MM XIENCE PROA. ADDITIONALLY THE WRONG DEVICE WAS RETURNED AND THE COMPLAINT DEVICE WAS MIXED UP AND INADVERTENTLY DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. 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 AFTER UNPACKING A 3.5X23MM XIENCE PROA, IT WAS NOTED THAT THE STENT WAS MISSING AND THE BALLOON WAS DAMAGED (LOOKED LIKE LINES ON BALLOON). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT, THEREFORE ANOTHER DRUG-ELUTING DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215361 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 0010241

    Patients

    Seq Age Sex Outcome Treatment
    1