BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SYSTEM CAPSULES

    MDR report key: 20934523 · Received December 15, 2024

    Report

    Report Number
    3025305436-2024-00003
    Event Type
    Injury
    Date Received
    December 15, 2024
    Date of Event
    August 8, 2024
    Report Date
    December 13, 2024
    Manufacturer
    VIBRANT LTD
    Product Code
    QTN
    PMA / PMN Number
    DEN210052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 05-DEC-2024, VIBRANT RECEIVED AN ANONYMOUS VOLUNTARY MEDWATCH REPORT (REF: MW5162502) IN WHICH A PATIENT ALLEGEDLY EXPERIENCED A SEVERE ADVERSE EVENT CHARACTERIZED BY BOWEL/STERCORAL PERFORATION AFTER USING THE VIBRANT CAPSULES. ACCORDING TO THE REPORTER, THE PATIENT, WITH A MEDICAL HISTORY OF SIGNIFICANT CHRONIC PAIN, MULTIPLE BACK SURGERIES, INTRATHECAL PUMPS, AND OPIATE-INDUCED CONSTIPATION, WAS INITIALLY TREATED WITH VARIOUS CONSTIPATION REGIMENS, INCLUDING MOTILITY AGENTS. TWO MONTHS AFTER BEING PRESCRIBED THE VIBRANT CAPSULES, HE WAS ADMITTED TO THE ICU IN SEPTIC SHOCK AND UNRESPONSIVE, NECESSITATING INTUBATION AND INTENSIVE CARE MANAGEMENT. THE IMAGING UPON ADMISSION SHOWED NUMEROUS 10-15 NON-OBSTRUCTING METALLIC FOREIGN BODIES, CONCENTRATED IN THE SPLENIC FLEXURE AND DESCENDING COLON. REPEATED IMAGING REVEALED NO PROGRESSION OF THE METALLIC FOREIGN BODIES (VIBRANT CAPSULES) FROM THEIR INITIAL LOCATION. THE PATIENT SUBSEQUENTLY DEVELOPED PNEUMATOSIS INTESTINALIS AND CONTAINED COLONIC PERFORATION, REQUIRING SURGICAL INTERVENTION FOR EXTENSIVE NECROSIS OF THE BOWEL. DUE TO THE LACK OF INFORMATION PROVIDED IN THE MEDWATCH REPORT, VIBRANT IS UNABLE TO FOLLOW UP ON THE REPORTED EVENT. NO FACILITY, DEVICE, OR REPORTER INFORMATION WAS PROVIDED WITH WHICH TO LINK THIS EVENT TO A PHYSICIAN/FACILITY/USER. VIBRANT IS REPORTING THE EVENT IN RESPONSE TO THE USER-SUBMITTED MEDWATCH. NOTABLY, THE REPORTED EVENT IS VIBRANT OFF-LABEL USE, AS THE TREATMENT WAS PRESCRIBED FOR OPIATE-INDUCED CONSTIPATION, WHILE VIBRANT IS INDICATED FOR THE TREATMENT OF CHRONIC IDIOPATHIC CONSTIPATION. MOREOVER, THE USE OF INTRATHECAL PUMPS IS LISTED AS A WARNING IN VIBRANT IFU. VIBRANT MEDICAL ADVISOR REVIEWED THE AVAILABLE INFORMATION AND CONCLUDED THAT - IT IS UNLIKELY THAT THE VIBRANT CAPSULES HAD ANY ROLE IN THE PATIENT'S CONDITION, FURTHER INDICATING THAT IT SEEMS MORE PROBABLE THAT THE PATIENT DEVELOPED ISCHEMIC COLITIS INDEPENDENTLY, WHICH WAS THEN EXACERBATED DURING THE COLONOSCOPY, LEADING TO PERFORATION. IT CAN BE ALSO ASSUMED THAT THE PATIENT WAS TAKING VIBRANT TREATMENT FOR TWO MONTHS. DURING 2 MONTHS OF TREATMENT, 40 CAPSULES ARE EXPECTED TO BE TAKEN PER THE RECOMMENDED DOSE, WHILE 10-15 NON-OBSTRUCTING CAPSULES WERE SEEN IN THE IMAGING (THE INTERVALS BETWEEN THE TWO IMAGING IS UNKNOWN). THE AMOUNT OF NON-EXPELLED CAPSULES MIGHT SUGGEST THAT ABOUT 30 CAPSULES WERE EXPELLED. SINCE THE REPORTER DID NOT PROVIDE INFORMATION REGARDING THE DOSAGE AND DURATION OF THE VIBRANT TREATMENT, OR ITS RELATIONSHIP TO THE EVENT, THE CONCLUSIONS OF THE VIBRANT INVESTIGATION CANNOT BE DEFINITIVELY CONFIRMED OR DISMISSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 05-DEC-2024, VIBRANT RECEIVED AN ANONYMOUS VOLUNTARY MEDWATCH REPORT (REF: MW5162502) IN WHICH A PATIENT ALLEGEDLY EXPERIENCED A SEVERE ADVERSE EVENT CHARACTERIZED BY BOWEL/STERCORAL PERFORATION AFTER USING THE VIBRANT CAPSULES. ACCORDING TO THE REPORTER, THE PATIENT, WITH A MEDICAL HISTORY OF SIGNIFICANT CHRONIC PAIN, MULTIPLE BACK SURGERIES, INTRATHECAL PUMPS, AND OPIATE-INDUCED CONSTIPATION, WAS INITIALLY TREATED WITH VARIOUS CONSTIPATION REGIMENS, INCLUDING MOTILITY AGENTS. TWO MONTHS AFTER BEING PRESCRIBED THE VIBRANT CAPSULES, HE WAS ADMITTED TO THE ICU IN SEPTIC SHOCK AND UNRESPONSIVE, NECESSITATING INTUBATION AND INTENSIVE CARE MANAGEMENT. THE IMAGING UPON ADMISSION SHOWED NUMEROUS 10-15 NON-OBSTRUCTING METALLIC FOREIGN BODIES, CONCENTRATED IN THE SPLENIC FLEXURE AND DESCENDING COLON. REPEATED IMAGING REVEALED NO PROGRESSION OF THE METALLIC FOREIGN BODIES (VIBRANT CAPSULES) FROM THEIR INITIAL LOCATION. THE PATIENT SUBSEQUENTLY DEVELOPED PNEUMATOSIS INTESTINALIS AND CONTAINED COLONIC PERFORATION, REQUIRING SURGICAL INTERVENTION FOR EXTENSIVE NECROSIS OF THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366099 VIBRANT SYSTEM CAPSULES ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION QTN VIBRANT LTD DEN210052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| L| H