BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 18611250 · Received January 30, 2024

    Report

    Report Number
    2024168-2024-01248
    Event Type
    Death
    Date Received
    January 30, 2024
    Date of Event
    September 13, 2022
    Report Date
    January 30, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: ESTIMATED DATE OF DEATH. B3: ESTIMATED DATE OF EVENT . THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ADDITIONAL ADVERSE EVENTS REFERENCED IN B5 ARE BEING FILED UNDER A SEPARATED MDR#.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF 1- VERSUS 3-MONTH DUAL ANTIPLATELET THERAPY (DAPT) AMONG OLDER PATIENTS WITH HIGH BLEEDING RISK (HBR) FEATURES THAT UNDERWENT SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) IN A LARGE PROSPECTIVE MULTICENTER SERIES OF STUDIES. OUT OF A TOTAL OF 3,364 PATIENTS, 2,241 WERE =75 YEARS OLD. THE RISK OF DEATH OR MI WAS SIMILAR WITH 1- VS 3-MONTH DAPT IN PATIENTS =75 (8.5% VS 8.0%, ADJUSTED HR 0.95, 95% CI 0.69-1.30) AND <75 YEARS OLD (6.9% VS 7.8%, ADJUSTED HR 0.97, 95% CI 0.60-1.57; INTERACTION P-VALUE 0.478). BLEEDING ACADEMIC RESEARCH CONSORTIUM (BARC) TYPE 2-5 BLEEDING WAS CONSISTENTLY LOWER WITH 1- THAN WITH 3-MONTH DAPT IN PATIENTS =75 YEARS OLD (7.2% VS 9.4%, ADJUSTED HR 0.66, 95% CI 0.48-0.91) AND <75 YEARS OLD (9.7% VS 11.9%, ADJUSTED HR 0.86, 95% CI 0.57-1.29; INTERACTION P-VALUE 0.737). IN CONCLUSION, AMONG HBR PATIENTS UNDERGOING PCI, PATIENTS OLDER AND YOUNGER THAN 75 YEARS OF AGE DERIVED A CONSISTENT BENEFIT FROM 1- AS COMPARED WITH 3-MONTH DAPT IN TERMS OF BLEEDING REDUCTION WITH NO INCREASE IN ALL-CAUSE DEATH OR MI AT 1 YEAR. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN PATIENTS =75 YEARS AND <75 YEARS OLD CONCERNING THE RATE OF ALL-CAUSE DEATH OR MYOCARDIAL INFARCTION(MI) (8.2% VS. 7.4%, HR 1.11, 95% CI 0.85-1.45, P-VALUE 0.464) OR OF THE INDIVIDUAL ISCHEMIC ENDPOINTS FROM 1 TO 12 MONTHS AFTER INDEX PCI. AT 1-YEAR AFTER PCI, AMONG PATIENTS =75 YEARS THE COMPOSITE OF ALL-CAUSE DEATH OR MI OCCURRED IN 75 (8.5%) PATIENTS ON 1-MONTH DAPT AND 96 (8.0%) PATIENTS ON 3-MONTHS DAPT, DETERMINING A SIMILAR EFFECT OF THE TWO REGIMENS ON THIS OUTCOME (HR 0.95, 95% CI 0.69-1.30). SIMILARLY, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN 1- AND 3-MONTH DAPT CONCERNING ALL-CAUSE DEATH (HR 0.97, 95% CI 0.65-1.44), CARDIOVASCULAR DEATH (HR 0.97, 95% CI 0.56-1.70), MI (HR 0.77, 95% CI 0.47-1.27), DEFINITE OR PROBABLE STENT THROMBOSIS (HR 0.43, 95% CI 0.04- 4.53), TARGET LESION FAILURE (HR 0.96, 95% CI 0.65-1.41) OR ITS INDIVIDUAL COMPONENTS. STROKE TENDED TO BE LOWER WITH 1-MONTH THAN 3-MONTH DAPT. THESE EFFECTS WERE CONSISTENT IN PATIENTS <75 YEARS. DETAILS ARE LISTED IN THE ARTICLE, "ONE- VERSUS THREE-MONTH DAPT IN OLDER PATIENTS AT HIGH BLEEDING RISK UNDERGOING PCI: INSIGHTS FROM THE XIENCE SHORT DAPT GLOBAL PROGRAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383255 XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death