BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

    MDR report key: 11679617 · Received April 16, 2021

    Report

    Report Number
    2024168-2021-03221
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 25, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648233241
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED LABELING PROBLEM WAS 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED LABELING ISSUE APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. THE XIENCE SKYPOINT DEVICE IS NOT CURRENTLY COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INVENTORY CLEARANCE OF THE HOSPITAL IT WAS NOTED THAT A 3.0X18MM XIENCE SKYPOINT HAD A DIFFERENT LOT NUMBER BETWEEN THE MANUFACTURING LABEL AND THE JAPANESE LABEL OF THE XIENCE SKYPOINT. THE DEVICE WAS NOT UNPACKED AND NOT USED. THE MANUFACTURING LABEL HAS LOT NUMBER 0090841 AND THE JAPANESE LABEL HAS 0090741. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. BASED ON RE-REVIEW OF THIS EVENT, THIS EVENT WOULD NOT HAVE BEEN REPORTABLE BECAUSE THE DEVICE MARKING/LABELING ISSUE OF LOT # DOES NOT IMPACT THE USE OF THE DEVICE AND THERE IS NO POTENTIAL FOR A SERIOUS INJURY. HOWEVER, SINCE THE INITIAL REPORT HAS ALREADY BEEN FILED, THIS EVENT MUST REMAIN REPORTABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DURING INVENTORY CLEARANCE OF THE HOSPITAL IT WAS NOTED THAT A 3.0X18MM XIENCE SKYPOINT HAD A DIFFERENT LOT NUMBER BETWEEN THE MANUFACTURING LABEL AND THE (B)(6) LABEL OF THE XIENCE SKYPOINT. THE DEVICE WAS NOT UNPACKED AND NOT USED. THE MANUFACTURING LABEL HAS LOT NUMBER 0090841 AND THE (B)(6) LABEL HAS 0090741. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576382 XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1804300-18 0090841 08717648233241

    Patients

    Seq Age Sex Outcome Treatment
    1