BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 18735837 · Received February 19, 2024

    Report

    Report Number
    2024168-2024-02037
    Event Type
    Death
    Date Received
    February 19, 2024
    Date of Event
    January 1, 2015
    Report Date
    February 19, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, B3: DATE OF ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF 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 PROGLIDE DEVICE AND ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORTS. LITERATURE ATTACHMENT: ARTICLE TITLE ¿SELECTION OF VASCULAR CLOSURE DEVICES IN TRANSCATHETER AORTIC VALVE REPLACEMENT: SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS".

    Description of Event or Problem · 0

    THIS STUDY COMPARED THE RESULTS OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURES USING PROSTAR, PROGLIDE, AND NON-ABBOTT DEVICES TO CLOSE THE COMMON FEMORAL ARTERY. THE INTENTION OF THIS STUDY WAS TO COMPARE THE RATES OF VASCULAR COMPLICATION, BLEEDING, ACUTE KIDNEY INJURY, AND MORTALITY BETWEEN THE THREE DEVICES. THE RATE OF VASCULAR COMPLICATIONS WERE LOW IN ALL GROUPS; HOWEVER, INCLUDED THE FOLLOWING: DEATH, STENOSIS, PERFORATION, ACUTE KIDNEY INJURY, DISSECTION, OCCLUSION, DISTAL EMBOLIZATION, HEMATOMA, PSEUDOANEURYSM, BLEEDING (INCLUDING LIFE THREATENING), MEDICAL INTERVENTION (USE OF A BALLOON), SURGICAL INTERVENTION, TRANSFUSIONS, AND HOSPITALIZATION. MECHANISM OF PROGLIDE AND PROSTAR DEVICE FAILURES LINKED TO CLOSURE DEVICE FAILURES [UNSPECIFIED FAILURES/FAILURE TO ACHIEVE HEMOSTASIS], WHICH WOULD REQUIRE MEDICAL INTERVENTION TO ACHIEVE HEMOSTASIS. THE ARTICLE CONCLUDED THAT THE RATES OF VASCULAR COMPLICATIONS WERE SIGNIFICANTLY LOWER IN PROGLIDE COMPARED TO PROSTAR. BOTH THE PROGLIDE DEVICE AND NON-ABBOTT DEVICE HAD COMPARABLE RATES OF VASCULAR COMPLICATIONS. PROGLIDE HAD A LOWER RATE OF ACUTE KIDNEY INJURY AND RED BLOOD CELL TRANSFUSION COMPARED TO PROSTAR. THERE WERE NO SIGNIFICANT DIFFERENCE IN MEDICAL INTERVENTIONS AND MORTALITY AMONG THE THREE GROUPS. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, "SELECTION OF VASCULAR CLOSURE DEVICES IN TRANSCATHETER AORTIC VALVE REPLACEMENT: SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423722 PROSTAR XL SUTURE-MEDIATED CLOSURE VESSEL CLOSURE SUTURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death