BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER VASCULAR PLUG II

    MDR report key: 14838348 · Received June 27, 2022

    Report

    Report Number
    2135147-2022-00448
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    October 1, 2019
    Report Date
    July 19, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    KRD
    UDI-DI
    00811806010427
    PMA / PMN Number
    K071699
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, A PATIENT WITH RECURRENT HEMODIALYSIS TREATMENT UNDERWENT A SHUNT EMBOLISM BY AN 18 MM AMPLATZER VASCULAR PLUG II. AN EVENT OF THROMBOSIS WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW, AND NO DEVICE OR ADDITIONAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. B3: DATE IS ESTIMATED. H6: CLINICAL CODE 4582 WAS REMOVED AND CODE 4440 WAS ADDED.

    Description of Event or Problem · 0

    THE ARTICLE, ¿HEMODIALYSIS-RELATED PORTAL-SYSTEMIC ENCEPHALOPATHY: A RARE CAUSE OF RECURRENT ENCEPHALOPATHY AMONG PATIENTS ON MAINTENANCE HEMODIALYSIS" WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 50 YEARS OLD MALE WITH HISTORY OF DIABETES MELLITUS (DM) WITH MICROVASCULAR COMPLICATIONS, WAS INITIATED ON HEMODIALYSIS THROUGH RIGHT IJV CUFFED CATHETER FOLLOWING IRREVERSIBLE ACUTE ON CHRONIC KIDNEY DISEASE DUE TO SUPERADDED INFECTION-RELATED GN¿ ON UNDERLYING ADVANCED DIABETIC NEPHROPATHY. HE HAD LOW C3 LEVELS AND KIDNEY BIOPSY HAD SHOWN DIFFUSE PROLIFERATIVE GLOMERULONEPHRITIS WITH BACKGROUND DIABETIC NODULAR GLOMERULOSCLEROSIS, 5 OF 13 GLOMERULI SHOWED CELLULAR CRESCENTS. THE RENAL FUNCTION PROGRESSIVELY DETERIORATED DESPITE TRIAL OF STEROIDS. HIS PAST HISTORY WAS SIGNIFICANT FOR AN EPISODE OF ACUTE PANCREATITIS, ACUTE CORONARY SYNDROME ON MEDICAL MANAGEMENT AND REGULAR ALCOHOL CONSUMPTION. TWO MONTHS INTO HD HE DEVELOPED ACUTE ONSET ALTERED MENTAL STATUS. ON EXAMINATION, HE HAD GAIT INSTABILITY AND FLAPS. HIS SERUM AMMONIA LEVEL WAS ELEVATED (67 MMOL/L) DESPITE ACCEPTABLE UREA REDUCTION RATES ON HEMODIALYSIS. ULTRASOUND ABDOMEN SHOWED FATTY LIVER AND UPPER GI ENDOSCOPY SHOWED NO VARICES. LIVER STIFFNESS MEASUREMENT DONE USING ECHOSENS FIBROSCAN 402 SHOWED A MEDIUM STIFFNESS VALUE OF 7.5 KPA. IN THE ABSENCE OF ADVANCED CIRRHOSIS AND LACK OF CLINICALLY SIGNIFICANT PORTAL HYPERTENSION A CONTRAST CT OF ABDOMEN WAS DONE TO LOOK FOR ANY ABNORMAL PORTOSYSTEMIC COMMUNICATION. A TORTUOUS AND PROMINENT COLLATERAL VEIN FROM THE PORTAL VEIN WAS SEEN DRAINING TO THE LEFT RENAL VEIN. SHUNT EMBOLISM BY AN 18 MM AMPLATZER VASCULAR PLUG (AVRII) WAS DONE ON OCTOBER- 2019. FOLLOW UP CT SHOWED COMPLETE OCCLUSION OF COLLATERALS. HE WAS PUT ON ORAL ANTICOAGULATION IN VIEW OF THROMBOSIS OF COMMON ILIAC AND RIGHT EXTERNAL ILIAC VEINS AFTER PROCEDURE. POST-PROCEDURE, PATIENT IS UNDERGOING THRICE-WEEKLY HEMODIALYSIS OF 4 HOURS DURATION TILL DATE WITH NO FURTHER INCIDENCE OF ENCEPHALOPATHY. THE ARTICLE CONCLUDED, RECURRENT ENCEPHALOPATHY CAN OCCUR IN DIALYSIS PATIENTS DUE TO SYMPTOMATIC PSVS AND HRPSE SHOULD BE CONSIDERED EVEN IN NON-CIRRHOTIC CASES FOR EARLY DETECTION AND EFFECTIVE MANAGEMENT. THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS, FEROZ AZIZ, MD, DEPARTMENT OF NEPHROLOGY, ASTER MIMS HOSPITAL, NH 66, CALICUT, ROAD, CHANGUVETTY, KERALA 676501, INDIA.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017577 AMPLATZER VASCULAR PLUG II DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD ABBOTT MEDICAL 9-AVP2-018 00811806010427

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention