BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 17827547 · Received September 27, 2023

    Report

    Report Number
    2135147-2023-04208
    Event Type
    Injury
    Date Received
    September 27, 2023
    Report Date
    October 10, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF AMPLATZER VASCULAR PLUG WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH LEFT SIDED PELVIC PAIN. IT WAS REPORTED THAT POST PROCEDURE SURGICAL INTERVENTION AND HOSPITALIZATION WAS REQUIRED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE ARTICLE, "NUTCRACKER", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 53 YEAR OLD FEMALE PATIENT WITH AGGRAVATED LEFT SIDED PELVIC PAIN. IT WAS REPORTED ON AN UNKNOWN DATE, A DECISION WAS MADE TO IMPLANT AN UNKNOWN AMPLATZER VASCULAR PLUG TO EMBOLIZE THE LEFT OVARIAN VEIN WITH A CONCOMITANT 12X40MM NON-ABBOTT STENT IMPLANTED IN THE LEFT RENAL VEIN. PRE-PROCEDURALLY, IT WAS CONFIRMED THERE WAS LEFT RENAL VEIN STENOSIS, LEFT OVARIAN VEINS DILATATION, AND PELVIC VARICOSE VEINS. IT WAS LATER REPORTED 6 MONTHS LATER ON AN UNKNOWN DATE, RECANALIZATION OF THE LEFT OVARIAN VEIN WAS CAUSED BY COLLATERAL BLOOD VESSEL DEVELOPMENT. A DECISION WAS MADE TO IMPLANT A NON-ABBOTT PLUG IN THE RIGHT OVARIAN VEIN WITH CONCOMITANT SECONDARY STENT IMPLANT IN THE INFERIOR VENA CAVA OVERLAPPING THE STENT IN THE LEFT RENAL VEIN. THE PATIENT WAS DISCHARGED ON ANTICOAGULATION THERAPY. NO RECURRENCE OF PELVIC CONGESTION SYNDROME WAS CONFIRMED AND IT WAS CONFIRMED 6 MONTHS FOLLOWING THE SECOND PROCEDURE, THERE STENT IMPLANTS REMAINED IN PLACE, OCCLUSION OF THE BILATERAL OVARIN VEINS, AND WITHDRAWAL OF PELVIC VARICOSE. [THE PRIMARY AUTHOR OF THE ARTICLE WAS TAKIZAWA, SHIMADA GENERAL HOSPITAL, 288-0053 CHIBA, CHOSHI, HIGASHICHO, 5-3, JAPAN].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724377 AMPLATZER VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H