BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    MDR report key: 18184860 · Received November 21, 2023

    Report

    Report Number
    2024168-2023-12963
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 30, 2023
    Report Date
    January 5, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648233388
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D4: LOT NUMBER UPDATED FROM UNKNOWN TO 3021641.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL XIENCE SKYPOINT DEVICE REFERENCED IN B5 IS/ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LAD ARTERY. A 3.5X12MM XIENCE SKYPINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT KEPT HEAVILY MOVING AND THE FIRST STENT WAS IMPLANTED A BIT TOO PROXIMAL BUT REMAINED IN THE TARGET LESION. A SECOND 3.5X12MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO CROSS THE FIRST IMPLANTED STENT BUT MET RESISTANCE WITH THE IMPLANTED STENT, AND FAILED TO CROSS. DURING THE ATTEMPT TO CROSS, THE SDS WAS PULLED BACK AND RESISTANCE WAS MET WITH THE IMPLANTED STENT, AND THE SECOND STENT DISLODGED. A THIRD 3.5X18MM XIENCE STENT WAS USED TO CRUSH THE DISLODGED XIENCE STENT INTO THE VESSEL AND A FOURTH STENT WAS USED TO SUCCESSFULLY TREAT THE REST THE OF THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743843 XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 3021641 08717648233388

    Patients

    Seq Age Sex Outcome Treatment
    1 Male 3.50 X 12 XIENCE SKYPOINT