BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SYSTEM CAPSULES

    MDR report key: 18777295 · Received February 26, 2024

    Report

    Report Number
    3025305436-2024-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 13, 2024
    Manufacturer
    VIBRANT LTD
    Product Code
    QTN
    PMA / PMN Number
    DEN210052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT REPORTED CHOKING ON THE CAPSULE DUE TO ITS SIZE AND LACK OF EFFICACY. CHOKING ON CAPSULE DUE TO SIZE: THE PATIENT STATES THAT THE CAPSULES ARE LARGE, AND THEY HAVE CHOKED ON THEM SEVERAL TIMES. THIS IS THE FIRST REPORTED COMPLAINT OF CHOKING DUE TO THE CAPSULE. IN CLINICAL TRIALS, PATIENTS WITH SWALLOWING DIFFICULTY OF ANY KIND (ZENKER'S DIVERTICULUM, DYSPHAGIA, ESOPHAGEAL STRICTURE, EOSINOPHILIC ESOPHAGITIS, OR ACHALASIA) WERE EXCLUDED FROM PARTICIPATION, AS THESE CONDITIONS ARE CONTRAINDICATED TO VIBRANT USE (FOR FURTHER INFORMATION, REFER TO THE DEVICE INSTRUCTION FOR USE). FOLLOWING THIS REPORTING, THE OCCURRENCE RATE OF CHOKING DUE TO THE DEVICE IN POST-MARKETING IS (B)(4)%. ACCORDING TO THE PATIENT'S PHYSICIAN, THIS CHOKING INCIDENT DOES NOT INDICATE DEVICE MALFUNCTION: "VIBRANT IS A BIG CAPSULE, AND SO PATIENTS WILL SOMETIMES HAVE TROUBLE SWALLOWING IT, BUT THIS IS NO DIFFERENT THAN TAKING ANY OTHER LARGE PILL." THE SIZE OF VIBRANT'S CAPSULES IS COMPARABLE TO THE STANDARD SIZE OF VITAMIN CAPSULES IN THE U.S. VIBRANT CAPSULE DIMENSIONS ARE 24.5+ 0.1 MM LENGTH, 11.2+ 0.05 MM DIAMETER. CAPSULE SIZE IS WITHIN FDA-APPROVED DEVICE SPECIFICATIONS AND IS AVAILABLE ON THE VIBRANT WEBPAGE. RESERVED SAMPLES OF CAPSULES FROM LOT C01923 WERE PHYSICALLY CHECKED TO SEE THAT THEY ARE WITHIN SPECIFICATION AS DEFINED IN 120DGD REV 02 PRODUCT SPECIFICATION GEN 2.3. CAPSULES FOUND TO BE CONFORMING TO SPECIFICATION. THE PRODUCTION RECORDS: A REVIEW OF CAPSULES LOT# C01923 DHR DEMONSTRATED THAT THE CAPSULES WERE MANUFACTURED, TESTED, AND RELEASED ACCORDING TO VIBRANT SPECIFICATIONS. THE PATIENT REPORTED TO THE FDA THAT THEY HAD CHOKED ON CAPSULES SEVERAL TIMES, WITH EVENT ONSET ON 15 DEC 2023. HOWEVER, THE PATIENT CONTINUED TREATMENT AFTER THIS COMPLAINT AND PURCHASED A SECOND REFILL ON (B)(6) 2024. THE LAST CAPSULE ACTIVATION RECORDED IN THE VIBRANT SYSTEM WAS ON (B)(6) 2024. LACK OF EFFICACY- VIBRANT SYSTEM IS NOT EXPECTED TO ACHIEVE A 100% SUCCESS RATE. IN THE PHASE 3 CLINICAL TRIAL, THE VIBRATING CAPSULE ACHIEVED THE PRIMARY EFFICACY ENDPOINT WITH A RATE OF 39.3% OF PATIENTS OBTAINED AN INCREASE IN AT LEAST ONE COMPLETE SPONTANEOUS BOWEL MOVEMENT (CSBM1) AND 22.7% FOR CSBM2. THUS FAR, 7.11% OF THE PATIENTS REPORTED A LACK OF EFFICACY, A LOWER RATE THAN THE PHASE 3 CLINICAL TRIAL RESULTS.

    Description of Event or Problem · 0

    VIBRANT RECEIVED A USER SUBMITTED MEDWATCH REPORT (MW5150825) ON FEBRUARY 13, 2024, IN WHICH THE EVENT DESCRIPTION READS: "HAVE BEEN INGESTING VIBRANT CAPSULES. THEY ARE LARGE, AND I HAVE CHOCKED ON THEM NUMEROUS TIMES. THEY DO NOTHING TO IMPROVE MY CONSTIPATION.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322418 VIBRANT SYSTEM CAPSULES ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION QTN VIBRANT LTD C01923

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other IBSRELA.| LINZESS.