BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER VASCULAR PLUG

    MDR report key: 23091881 · Received September 18, 2025

    Report

    Report Number
    2135147-2025-05278
    Event Type
    Death
    Date Received
    September 18, 2025
    Date of Event
    January 1, 2011
    Report Date
    September 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    PMA / PMN Number
    K031810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CHRONIC KIDNEY DISEASE, HEMODIALYSIS, DIABETES MELLITUS, SMOKING HISTORY, PRIOR CEREBROVASCULAR ACCIDENT, LIVER DISEASE, PRIOR ABDOMINAL SURGERY, PRIOR ENDOSCOPY-PROVEN GASTROINTESTINAL BLEED, PRIOR GASTROINTESTINAL RESECTION, CONNECTIVE TISSUE DISEASE, VASCULITIS, AND PRIOR AORTIC SURGERY (OPEN ASCENDING/ARCH REPAIR, THORACIC ENDOVASCULAR AORTIC REPAIR, ENDOVASCULAR AORTIC REPAIR). COMPLICATIONS REPORTED INCLUDED DEATH, GASTROINTESTINAL BLEEDING, INFLAMMATION, MYOCARDIAL INFARCTION, CARDIOGENIC SHOCK, STROKE, BLEEDING, RENAL FAILURE, ISCHEMIA, PNEUMONIA, AND RESPIRATORY INSUFFICIENCY; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B2: DATE OF DEATH IS ESTIMATED. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE : GASTROINTESTINAL COMPLICATIONS AND VISCERAL CIRCULATION CHANGES AFTER INTENTIONAL CELIAC ARTERY EMBOLIZATION DURING COMPLEX ENDOVASCULAR AORTIC REPAIR.

    Description of Event or Problem · 0

    THE ARTICLE, "GASTROINTESTINAL COMPLICATIONS AND VISCERAL CIRCULATION CHANGES AFTER INTENTIONAL CELIAC ARTERY EMBOLIZATION DURING COMPLEX ENDOVASCULAR AORTIC REPAIR", WAS REVIEWED. THE ARTICLE PRESENTED RETROSPECTIVE, SINGLE CENTER STUDY TO REPORT THE LONG-TERM OUTCOMES AND ADAPTIVE CHANGES IN COLLATERAL VISCERAL CIRCULATION FOLLOWING CELIAC ARTERY EMBOLIZATION (CAE) DURING COMPLEX ENDOVASCULAR AORTIC REPAIR. DEVICES INCLUDED IN THE STUDY WERE AMPLATZER VASCULAR PLUG AND UNKNOWN COILS. THE ARTICLE CONCLUDED THAT CAE DURING COMPLEX ENDOVASCULAR AORTIC REPAIR (EVAR) IS A USEFUL ADJUNCT TO INCREASE SEAL ZONE IN SELECT PATIENTS; HOWEVER, MESENTERIC COMPLICATIONS OCCUR IN 14% OF THE PATIENTS OVER A 90-DAY POSTOPERATIVE PERIOD, AND PATIENTS WITH MESENTERIC COMPLICATIONS HAVE A HIGHER LONG-TERM ALL-CAUSE MORTALITY. CAE SHOULD BE A TECHNIQUE WITHIN THE TOOLBOX OF VASCULAR SURGEONS FOR URGENT CIRCUMSTANCES THAT DO NOT ALLOW FOR CELIAC PRESERVATION. CAREFUL SELECTION OF CANDIDATES FOR CAE AND EARLY POSTOPERATIVE SURVEILLANCE OF COLLATERAL PATHWAYS MAY HELP WITH PREVENTION AND EARLY IDENTIFICATION OF LONG-TERM VISCERAL COMPLICATIONS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS JASON LEE, DIVISION OF VASCULAR SURGERY, STANFORD UNIVERSITY MEDICAL CENTER, 780 WELCH RD, SUITE CJ350, MC5639, PALO ALTO, CA 94304, WITH CORRESPONDING E-MAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM DECEMBER 2011 TO NOVEMBER 2023. A TOTAL OF 70 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 53 (75.7%) RECEIVED AN ABBOTT DEVICE AND 2 (2.9%) RECEIVED A COMBO OF ABBOTT AND UNKNOWN COIL DEVICES. THE AVERAGE AGE WAS 71.2 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, CORONARY ARTERY DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CHRONIC KIDNEY DISEASE, HEMODIALYSIS, DIABETES MELLITUS, SMOKING HISTORY, PRIOR CEREBROVASCULAR ACCIDENT, LIVER DISEASE, PRIOR ABDOMINAL SURGERY, PRIOR ENDOSCOPY-PROVEN GASTROINTESTINAL BLEED, PRIOR GASTROINTESTINAL RESECTION, CONNECTIVE TISSUE DISEASE, VASCULITIS, AND PRIOR AORTIC SURGERY (OPEN ASCENDING/ARCH REPAIR, THORACIC ENDOVASCULAR AORTIC REPAIR, ENDOVASCULAR AORTIC REPAIR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868234 AMPLATZER VASCULAR PLUG DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL UNK AMPLATZER VASCULAR PLUG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death