BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZUM

    MDR report key: 20238981 · Received September 17, 2024

    Report

    Report Number
    2124215-2024-57518
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    October 1, 2023
    Report Date
    September 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED PERFORMANCE ALLEGATION IN THIS COMPLAINT HAS NOT BEEN CONFIRMED, AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. WITHOUT A RETURNED DEVICE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF BLOOD LOSS, DISCOMFORT, DYSURIA, HEMATURIA, URINARY RETENTION, URETHRAL STENOSIS/STRICTURE ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. ACCORDING TO THIS INFORMATION, A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. ABID A, PIPERDI H, BABAR M, ET AL. MINIMALLY INVASIVE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLASIA IN THE GERIATRIC POPULATION: A SYSTEMATIC REVIEW. PROSTATE. 2024;84:895-908. DOI:10.1002/PROS.24717.

    Additional Manufacturer Narrative · 0

    ABID A, PIPERDI H, BABAR M, ET AL. MINIMALLY INVASIVE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLASIA IN THE GERIATRIC POPULATION: A SYSTEMATIC REVIEW. PROSTATE. 2024;84:895-908. DOI:10.1002/PROS.24717.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THE OBJECTIVE OF THIS IS A SYSTEMATIC REVIEW RELATED TO MINIMALLY INVASIVE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLASIA IN THE GERIATRIC POPULATION. IN THIS STUDY THERE WAS EVALUATED THE EFFICACY, SAFETY, AND PROCEDURAL CHARACTERISTICS OF MISTS IN GERIATRIC PATIENTS. WITH BPH. AROUND 292 STUDIES WERE SELECTED 32 (N= 3972 PATIENTS) MET INCLUSION CRITERIA AND ASSESSED PROSTATIC ARTERY EMBOLIZATION (PAE}, REZURN, GREENLIGHT, HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP), THULIUM LASER. ENUCLEATION OF THE PROSTATE (THULEP), DIODE LASER ENUDEATION OF THE PROSTATE (DILEP), AND AQUABLATION. EXCEPT FOR REZUM, ALL MISTS REQUIRED A PLANNED OVERNIGHT STAY. WHILE PAE AND REZUM COULD BE PERFORMED UNDER LOCAL ANESTHESIA, THE OTHER MISTS NEEDED GENERAL OR SPINAL ANESTHESIA. POSTOPERATIVE CATHETERIZATION DURATION WAS LONGEST FOR PAE (MEDIAN 14 DAYS) AND REZUM (21 DAYS) AND SHORTEST FOR GREENLIGHT (1.9 DAYS). AT 12 MONTHS POSTOPERATIVELY, ALL MISTS EXHIBITED SIGNIFICANT PERCENT CHANGES IN INTERNATIONAL PROSTATE SYRNPTOM SCORE (MEDIAN -69.9%) AND. QUALITY OF LIFE (MEDIAN -725%). CLAVIEN:DINDO GRADE 1 AES RANGED WIDELY, WITH PAE (5.8%-36:8%), REZUM (0%-"62:1%), AND GREENLIGHT (0%-67.6%) HAVING THE LARGEST RANGE, AND HOLEP (0%-9.5%), THULEP (2%-6.9%), AND DILEP (5%-:17.5%) HAVING THE SMALLEST. PAE, REZUM, DILEP, AND AQUABLATION REPORTED NO SIGNIFICANT CHANGES IN THE LNTEMATIONAL INDEX OF ERECTILE FUNCTION. AS A CONCLUSION OF THIS REVISION, ALTHOUGH ALL THE M.ISTS REVIEWED IN THIS STUDY EFFECTIVELY TREAT BPH IN GERIATRIC PATIENTS, DIFFERENCES IN PROCEDURAL CHARACTERISTICS AND SAFETY PROFILES ACROSS MISTS WERE CONSIDERABLE. PHYSICIANS SHOULD USE SHARED DECISION-MAKING PROCESSES, CONSIDERING RISKS AND PATIENT CHARACTERISTICS, WHEN CHOOSING A SUITABLE TREATMENT OPTION FOR THEIR PATIENTS. THE FACTORS AFFECTING THIS REVISION WERE: URINARY RETENTION, URETHRAL BLEEDING, HEMATURIA, URETHRAL STRUCTURE, DYSURIA, AND PHYSICAL DISCOMFORT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA A JOURNAL ARTICLE THAT THE OBJECTIVE OF THIS IS A SYSTEMATIC REVIEW RELATED TO MINIMALLY INVASIVE SURGICAL THERAPIES FOR BENIGN PROSTATIC HYPERPLASIA IN THE GERIATRIC POPULATION. IN THIS STUDY THERE WAS EVALUATED THE EFFICACY, SAFETY, AND PROCEDURAL CHARACTERISTICS OF MISTS IN GERIATRIC PATIENTS. WITH BPH. AROUND 292 STUDIES WERE SELECTED 32 (N= 3972 PATIENTS) MET INCLUSION CRITERIA AND ASSESSED PROSTATIC ARTERY EMBOLIZATION (PAE}, REZURN, GREENLIGHT, HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP), THULIUM LASER. ENUCLEATION OF THE PROSTATE (THULEP), DIODE LASER ENUDEATION OF THE PROSTATE (DILEP), AND AQUABLATION. EXCEPT FOR REZUM, ALL MISTS REQUIRED A PLANNED OVERNIGHT STAY. WHILE PAE AND REZUM COULD BE PERFORMED UNDER LOCAL ANESTHESIA, THE OTHER MISTS NEEDED GENERAL OR SPINAL ANESTHESIA. POSTOPERATIVE CATHETERIZATION DURATION WAS LONGEST FOR PAE (MEDIAN 14 DAYS) AND REZUM (21 DAYS) AND SHORTEST FOR GREENLIGHT (1.9 DAYS). AT 12 MONTHS POSTOPERATIVELY, ALL MISTS EXHIBITED SIGNIFICANT PERCENT CHANGES IN INTERNATIONAL PROSTATE SYMPTOM SCORE (MEDIAN-69.9%) AND. QUALITY OF LIFE (MEDIAN-725%). CLAVIEN:DINDO GRADE 1 AES RANGED WIDELY, WITH PAE (5.8%-36:8%), REZUM (0%-"62:1%), AND GREENLIGHT (0%-67.6%) HAVING THE LARGEST RANGE, AND HOLEP (0%-9.5%), THULEP (2%-6.9%), AND DILEP (5%-:17.5%) HAVING THE SMALLEST. PAE, REZUM, DILEP, AND AQUABLATION REPORTED NO SIGNIFICANT CHANGES IN THE INTENTIONAL INDEX OF ERECTILE FUNCTION. AS A CONCLUSION OF THIS REVISION, ALTHOUGH ALL THE MISTS REVIEWED IN THIS STUDY EFFECTIVELY TREAT BPH IN GERIATRIC PATIENTS, DIFFERENCES IN PROCEDURAL CHARACTERISTICS AND SAFETY PROFILES ACROSS MISTS WERE CONSIDERABLE. PHYSICIANS SHOULD USE SHARED DECISION-MAKING PROCESSES, CONSIDERING RISKS AND PATIENT CHARACTERISTICS, WHEN CHOOSING A SUITABLE TREATMENT OPTION FOR THEIR PATIENTS. THE FACTORS AFFECTING THIS REVISION WERE: URINARY RETENTION, URETHRAL BLEEDING, HEMATURIA, URETHRAL STRUCTURE, DYSURIA, AND PHYSICAL DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740514 REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other