BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SKYPOINT¿

    MDR report key: 18983454 · Received March 26, 2024

    Report

    Report Number
    2024168-2024-03707
    Event Type
    Injury
    Date Received
    March 26, 2024
    Date of Event
    March 5, 2024
    Report Date
    July 1, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    UDI-DI
    08717648230592
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE WAS NOT REPORTED AND SIMILARITY COULD NOT BE DETERMINED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. LOT HISTORY RECORD (LHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A QUERY OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE A SPECIFIC FAILURE MODE WAS NOT REPORTED AND SIMILARITY COULD NOT BE DETERMINED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES; HOWEVER, THE TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. D1 CORRECTION: BRAND NAME UPDATED. D2A CORRECTION: COMMON DEVICE NAME UPDATED. D3 CORRECTION: NAME, ADDRESS UPDATED. D4 CORRECTION: CATALOG # UPDATED FROM 1800275-33 TO 1800275-28. D4 CORRECTION: PRIMARY UDI NUMBER UPDATED FROM (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. B3, D6A, D6B: DATES ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS EXPLANTED AND FAULTY/DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985988 XIENCE SKYPOINT¿ CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. 1800275-28 2110241 08717648230592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention