BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 18286309 · Received December 7, 2023

    Report

    Report Number
    2029214-2023-02344
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    January 10, 2022
    Report Date
    December 7, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID UNK-NV-CONCERTO (LOT: UNKNOWN); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A G2: CITATION: AUTHORS: BHATIA, S., ACHARYA, V., JALAEIAN, H., KUMAR, J., BRYANT, E., RICHARDSON, A., MALKOVA, K., HARWARD, S., SINHA, V., KABLY, I., & KAVA, B. R.. EFFECT OF PROSTATE ARTERY EMBOLIZATION ON ERECTILE FUNCTION ¿ A SINGLE CENTER EXPERIENCE OF 167 PATIENTS.. THE JOURNAL OF SEXUAL MEDICINE 19(4), 594¿602. 2022. HTTPS://DOI.ORG/10.1016/J.JSXM.2022.01.0 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    BHATIA S, ACHARYA V, JALAEIAN H, ET AL. EFFECT OF PROSTATE ARTERY EMBOLIZATION ON ERECTILE FUNCTION ¿ A SINGLE CENTER EXPERIENCE OF 167 PATIENTS. THE JOURNAL OF SEXUAL MEDICINE. 2022;19(4):594-602. DOI:10.1016/J.JSXM.2022.01.006 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF STROKE, UROSEPSIS, HYPONATREMIA, DIMINISHED EJACULATION, URINARY TRACT INFECTION, PROS TATITIS, EPIDIDYMITIS, ACUTE URINARY OBSTRUCTION, NOCTURIA, URGENCY, FREQUENCY, INCONTINENCE, DYSURIA, PENILE DISCOLORATION, URINARY RETENTION, HEMATURIA, HEMATOCHEZIA, AND HEMATOSPERMIA IN ASSOCIATION WITH PROSTATE ARTERY CONCERTO COIL EMBOLIZATION. FOR THE PATIENTS WHO EXPERIENCED STROKE, UROSEPSIS AND HYPONATREMIA, THE PATIENTS DISCHARGED FROM THE HOSPITAL IN 5 DAYS WITHOUT ANY LONG TERM SY MPTOMS. THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE THE EFFICACY OF PROSTATE ARTERY COIL EMBOLIZATION IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA AND THE EFFECT IT HAS ON ERECTILE FUNCTION.  THE AUTHORS REVIEWED 167 CASES OF MALE PATIENTS TREATED FOR BENIGN PROSTATE HYPERPLASIA (BPH) USING COIL EMBOLIZATION OF THE PROSTATE ARTERY. THE PATIENT'S WERE FOLLOWED ARE 1, 3, 6, AND 12 MONTHS. FOR FOLLOW UP THE PATIENT'S RATED THEIR ERECTILE FUNCTION USING SHIM QUESTIONNAIRE AND THE PATIENT'S QUALITY OF LIFE WITH THE IPSS-QOL QUESTIONNAIRE. THERE WAS NO ADVERSE IMPACT ON ERECTILE FUNCTION. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE CONCERTO COILS. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: UROSPESIS STROKE HYPONATREMIA EPIDIDYMITIS PROSTATITIS URINARY TRACT INFECTION DIMINISHED EJACULATION ACUTE URINARY OBSTRUCTION NOCTURIA URINARY RETENTION HEMATURIA HEMAOCHEZIA HEMATOSPERMIA PENILE DISCOLORATION DYSURIA INCONTINENCE FREQUENCY URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878129 CONCERTO DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CONCERTO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization