BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOZENE MICROSPHERES

    MDR report key: 15176425 · Received August 5, 2022

    Report

    Report Number
    2134265-2022-08386
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    February 2, 2021
    Report Date
    August 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: ARTICLE PUBLICATION DATE USED. INITIAL REPORTER FACILITY NAME: DEPARTMENT OF UROLOGY, SCHOOL OF MEDICINE, UNIVERSITY OF ST. GALLEN.

    Additional Manufacturer Narrative · 0

    CORRECTION - H6 UPDATED TO: SKIN INFLAMMATION/IRRITATION AND SEXUAL DYSFUNCTION. B3 - DATE OF EVENT: ARTICLE PUBLICATION DATE USED. E1 - INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. ABSTRACT: BACKGROUND: PROSTATIC ARTERY EMBOLISATION (PAE) FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC OBSTRUCTION (LUTS/BPO) STILL REMAINS UNDER INVESTIGATION. OBJECTIVE: TO COMPARE THE EFFICACY AND SAFETY OF PAE AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) IN THE TREATMENT OF LUTS/BPO AT 2 YR OF FOLLOW-UP. DESIGN, SETTING, AND PARTICIPANTS: A RANDOMISED, OPEN-LABEL TRIAL WAS CONDUCTED. THERE WERE 103 PARTICIPANTS AGED GREATER THAN OR EQUAL TO 40 YR WITH REFRACTORY LUTS/BPO. INTERVENTION: PAE VERSUS TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: INTERNATIONAL PROSTATE SYMPTOMS SCORE (IPSS) AND OTHER QUESTIONNAIRES, FUNCTIONAL MEASURES, PROSTATE VOLUME, AND ADVERSE EVENTS WERE EVALUATED. CHANGES FROM BASELINE TO 2 YR WERE TESTED FOR DIFFERENCES BETWEEN THE TWO INTERVENTIONS WITH STANDARD TWO-SIDED TESTS. RESULTS AND LIMITATIONS: THE MEAN REDUCTION IN IPSS AFTER 2 YR WAS 9.21 POINTS AFTER PAE AND 12.09 POINTS AFTER TURP (DIFFERENCE OF 2.88 [95% CONFIDENCE INTERVAL 0.04 - 5.72]; P = 0.047). SUPERIORITY OF TURP WAS ALSO FOUND FOR MOST OTHER PATIENT-REPORTED OUTCOMES EXCEPT FOR ERECTILE FUNCTION. PAE WAS LESS EFFECTIVE THAN TURP REGARDING THE IMPROVEMENT OF MAXIMUM URINARY FLOW RATE (3.9 VS 10.23 ML/S, DIFFERENCE OF -6.33 [-10.12 TO -2.54]; P < 0.001), REDUCTION OF POSTVOID RESIDUAL URINE (62.1 VS 204.0 ML; 141.91 [43.31 - 240.51]; P = 0.005), AND REDUCTION OF PROSTATE VOLUME (10.66 VS 30.20 ML; 19.54 [7.70 - 31.38]; P = 0.005). ADVERSE EVENTS WERE LESS FREQUENT AFTER PAE THAN AFTER TURP (TOTAL OCCURRENCE N = 43 VS 78, P = 0.005), BUT THE DISTRIBUTION AMONG SEVERITY CLASSES WAS SIMILAR. TEN PATIENTS (21%) WHO INITIALLY UNDERWENT PAE REQUIRED TURP WITHIN 2 YR DUE TO UNSATISFYING CLINICAL OUTCOMES, WHICH PREVENTED FURTHER ASSESSMENT OF THEIR OUTCOMES AND THEREFORE, REPRESENTS A LIMITATION OF THE STUDY. CONCLUSIONS: INFERIOR IMPROVEMENTS IN LUTS/BPO AND A RELEVANT RE-TREATMENT RATE ARE FOUND 2 YR AFTER PAE COMPARED WITH TURP. PAE IS ASSOCIATED WITH FEWER COMPLICATIONS THAN TURP. THE DISADVANTAGES OF PAE REGARDING FUNCTIONAL OUTCOMES SHOULD BE CONSIDERED FOR PATIENT SELECTION AND COUNSELLING.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. ABSTRACT: BACKGROUND: PROSTATIC ARTERY EMBOLISATION (PAE) FOR THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS SECONDARY TO BENIGN PROSTATIC OBSTRUCTION (LUTS/BPO) STILL REMAINS UNDER INVESTIGATION. OBJECTIVE: TO COMPARE THE EFFICACY AND SAFETY OF PAE AND TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) IN THE TREATMENT OF LUTS/BPO AT 2 YR OF FOLLOW-UP. DESIGN, SETTING, AND PARTICIPANTS: A RANDOMISED, OPEN-LABEL TRIAL WAS CONDUCTED. THERE WERE 103 PARTICIPANTS AGED GREATER THAN OR EQUAL TO 40 YR WITH REFRACTORY LUTS/BPO. INTERVENTION: PAE VERSUS TURP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: INTERNATIONAL PROSTATE SYMPTOMS SCORE (IPSS) AND OTHER QUESTIONNAIRES, FUNCTIONAL MEASURES, PROSTATE VOLUME, AND ADVERSE EVENTS WERE EVALUATED. CHANGES FROM BASELINE TO 2 YR WERE TESTED FOR DIFFERENCES BETWEEN THE TWO INTERVENTIONS WITH STANDARD TWO-SIDED TESTS. RESULTS AND LIMITATIONS: THE MEAN REDUCTION IN IPSS AFTER 2 YR WAS 9.21 POINTS AFTER PAE AND 12.09 POINTS AFTER TURP (DIFFERENCE OF 2.88 [(B)(4) CONFIDENCE INTERVAL 0.04 - 5.72]; P = 0.047). SUPERIORITY OF TURP WAS ALSO FOUND FOR MOST OTHER PATIENT-REPORTED OUTCOMES EXCEPT FOR ERECTILE FUNCTION. PAE WAS LESS EFFECTIVE THAN TURP REGARDING THE IMPROVEMENT OF MAXIMUM URINARY FLOW RATE (3.9 VS 10.23 ML/S, DIFFERENCE OF -6.33 [-10.12 TO -2.54]; P < 0.001), REDUCTION OF POSTVOID RESIDUAL URINE (62.1 VS 204.0 ML; 141.91 [43.31 - 240.51]; P = 0.005), AND REDUCTION OF PROSTATE VOLUME (10.66 VS 30.20 ML; 19.54 [7.70 - 31.38]; P = 0.005). ADVERSE EVENTS WERE LESS FREQUENT AFTER PAE THAN AFTER TURP (TOTAL OCCURRENCE N = 43 VS 78, P = 0.005), BUT THE DISTRIBUTION AMONG SEVERITY CLASSES WAS SIMILAR. TEN PATIENTS ((B)(4)) WHO INITIALLY UNDERWENT PAE REQUIRED TURP WITHIN 2 YR DUE TO UNSATISFYING CLINICAL OUTCOMES, WHICH PREVENTED FURTHER ASSESSMENT OF THEIR OUTCOMES AND THEREFORE, REPRESENTS A LIMITATION OF THE STUDY. CONCLUSIONS: INFERIOR IMPROVEMENTS IN LUTS/BPO AND A RELEVANT RE-TREATMENT RATE ARE FOUND 2 YR AFTER PAE COMPARED WITH TURP. PAE IS ASSOCIATED WITH FEWER COMPLICATIONS THAN TURP. THE DISADVANTAGES OF PAE REGARDING FUNCTIONAL OUTCOMES SHOULD BE CONSIDERED FOR PATIENT SELECTION AND COUNSELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708004 EMBOZENE MICROSPHERES EMBOLIC DEVICE NAJ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other