BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 18187861 · Received November 21, 2023

    Report

    Report Number
    2024168-2023-12981
    Event Type
    Death
    Date Received
    November 21, 2023
    Date of Event
    November 20, 2019
    Report Date
    November 21, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE CATALOGUE NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE PART AND LOT NUMBERS WERE NOT REPORTED. THE PATIENT EFFECT OF DEATH IS LISTED IN THE ELECTRONIC PROSTAR INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT OF USE OF THE DEVICE. BASED ON THE ARTICLE INFORMATION, 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 PROSTAR ADVERSE PATIENT EFFECTS REFERENCED IN B5 IS CAPTURED UNDER SEPARATE MEDWATCH REPORT. THE ADDITIONAL PROGLIDE DEVICE(S) REFERENCED IN B5 IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. ATTACHMENT: ARTICLE TITLED, "VASCULAR COMPLICATIONS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION, USING MANTA (COLLAGEN PLUG-BASED) VERSUS PROSTAR (SUTURE-BASED), FROM A FRENCH SINGLE-CENTER RETROSPECTIVE REGISTRY".

    Description of Event or Problem · 0

    THIS STUDY COMPARED THE RESULTS OF A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING PROSTAR DEVICES VERSUS USING A NON-ABBOTT DEVICE TO CLOSE THE COMMON FEMORAL ARTERY. THE INTENTION OF THIS STUDY WAS TO COMPARE THE VASCULAR COMPLICATION RATES BETWEEN THE TWO DEVICES. ONE PROSTAR WAS PLACED AT ALL LARGE BORE ACCESS SITES. ONE NON-ABBOTT DEVICE WAS PLACED AT ALL LARGE BORE ACCESS SITES. THE RATE OF VASCULAR COMPLICATIONS WERE LOW IN BOTH GROUPS; HOWEVER FOR PROSTAR, INCLUDED THE FOLLOWING: A DEATH, PSEUDOANEURYSM, ARTERIOVENOUS FISTULA, DISSECTION, HEMORRHAGE, MEDICAL INTERVENTION (USE OF A COVERED STENT), SURGICAL INTERVENTION, TRANSFUSIONS, AND HOSPITALIZATION. MECHANISM OF PROSTAR DEVICE FAILURES LINKED TO CLOSURE DEVICE FAILURES [UNSPECIFIED FAILURES/FAILURE TO ACHIEVE HEMOSTASIS], WHICH WOULD REQUIRE MEDICAL INTERVENTION TO ACHIEVE HEMOSTASIS. ADDITIONALLY THE ARTICLE MENTIONED PREVIOUS STUDIES NOTED MAJOR AND MINOR VASCULAR COMPLICATIONS [BLEEDING] ASSOCIATED WITH THE USE OF PROGLIDE DEVICES. THE ARTICLE CONCLUDED THAT BOTH THE NON-ABBOTT DEVICE AND THE PROSTAR DEVICE HAD COMPARABLE RATES OF VASCULAR COMPLICATIONS; HOWEVER, THERE WERE HIGHER RATES OF BLEEDING COMPLICATIONS THAT REQUIRED THE USE OF A COVERED STENT FOR PROSTAR. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, "VASCULAR COMPLICATIONS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION, USING MANTA (COLLAGEN PLUG-BASED) VERSUS PROSTAR (SUTURE-BASED), FROM A FRENCH SINGLE-CENTER RETROSPECTIVE REGISTRY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986440 PROSTAR XL SUTURE-MEDIATED CLOSURE VESSEL CLOSURE SUTURE MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death