VIBRANT SYSTEM CAPSULES

Additional Manufacturer Narrative

VIBRANT ASSESSED THIS EVENT AS DELAYED CAPSULE EXPULSION INVOLVING MULTIPLE VIBRANT CAPSULES IN ONE PATIENT. THE PATIENT FIRST REPORTED CONCERN REGARDING CAPSULE EXPULSION TO VIBRANT ON (B)(6) 2026. AN ABDOMINAL X-RAY WAS PERFORMED ON (B)(6) 2026, APPROXIMATELY 15 DAYS AFTER FIRST CAPSULE INTAKE AND ON THE SAME DATE AS THE LAST KNOWN CAPSULE INTAKE. VOLUNTARY MEDWATCH REPORTS WERE SUBSEQUENTLY SUBMITTED TO FDA ON (B)(6) 2026, AND VIBRANT BECAME AWARE OF THOSE MEDWATCH REPORTS ON (B)(6) 2026. DELAYED CAPSULE EXPULSION IS AN INHERENT RISK OF THE VIBRANT CAPSULE AND IS ADDRESSED IN THE FDA-CLEARED INSTRUCTIONS FOR USE, WHICH INSTRUCTS PATIENTS TO CONSULT THEIR PHYSICIAN IF A CAPSULE IS NOT EXPELLED WITHIN TWO WEEKS. THE IFU ALSO IDENTIFIES ABDOMINAL PAIN, ABDOMINAL DISTENSION, ABDOMINAL DISCOMFORT, AND FLATULENCE AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THE DEVICE. BASED ON THE AVAILABLE INFORMATION, THE TREATING PHYSICIAN ADVISED THAT THE IMAGING DID NOT APPEAR TO SHOW OBSTRUCTION. VIBRANT'S MEDICAL ADVISOR REVIEWED THE AVAILABLE INFORMATION AND INDICATED THAT NO FURTHER ACTION WAS REQUIRED. NO DEVICE MALFUNCTION WAS IDENTIFIED, AND BATCH RECORD REVIEW FOR C02125 FOUND NO ISSUE OR NONCONFORMANCE APPLICABLE TO THIS REPORT. ALTHOUGH THE MEDWATCH REPORT WAS SUBMITTED ANONYMOUSLY, THE DETAILS ARE CONSISTENT WITH A COMPLAINT ALREADY KNOWN TO VIBRANT. VIBRANT DID NOT ASSESS THE ORIGINAL COMPLAINT INFORMATION AVAILABLE AT THAT TIME AS MEETING MDR REPORTABILITY CRITERIA. THIS MANUFACTURER REPORT IS SUBMITTED IN RESPONSE TO VOLUNTARY MEDWATCH REPORT MW5188455 AND IS ASSOCIATED WITH THE SAME PATIENT EVENT DESCRIBED IN RELATED MEDWATCH REPORTS MW5188451, MW5188452, MW5188453, MW5188455, MW5188456, MW5188457, MW5188458, MW5188459, AND MW5188460.

Description of Event or Problem

VIBRANT BECAME AWARE ON (B)(6) 2026 OF VOLUNTARY MEDWATCH REPORTS MW5188451 THROUGH MW5188460, WHICH APPEAR TO DESCRIBE THE SAME PATIENT EVENT INVOLVING MULTIPLE VIBRANT CAPSULES REPORTEDLY NOT EXPELLED AFTER ORAL INGESTION. THIS REPORT IS ONE OF TEN MANUFACTURER RESPONSES SUBMITTED FOR THE RELATED MEDWATCH REPORTS. ALTHOUGH THE MEDWATCH REPORTS WERE SUBMITTED ANONYMOUSLY TO FDA ON 19-MAY-2026, THE EVENT DETAILS ARE CONSISTENT WITH A COMPLAINT PREVIOUSLY REPORTED TO VIBRANT. ACCORDING TO VIBRANT RECORDS, THE PATIENT INITIATED VIBRANT TREATMENT ON (B)(6) 2026 AND FIRST REPORTED CONCERN REGARDING DELAYED CAPSULE EXPULSION TO VIBRANT ON (B)(6) 2026. AN ABDOMINAL X-RAY WAS PERFORMED ON (B)(6) 2026, APPROXIMATELY 15 DAYS AFTER FIRST CAPSULE INTAKE AND ON THE SAME DATE AS THE LAST KNOWN CAPSULE INTAKE, AND REPORTEDLY SHOWED MULTIPLE CAPSULES IN TRANSIT. THE PATIENT REPORTED ABDOMINAL BLOATING AND PAIN. BASED ON THE AVAILABLE INFORMATION, THE TREATING PHYSICIAN REVIEWED THE IMAGING AND ADVISED THAT IT DID NOT APPEAR TO SHOW OBSTRUCTION. THE PHYSICIAN REPORTEDLY RECOMMENDED GOLYTELY AND INSTRUCTED THE PATIENT TO SEEK EMERGENCY CARE IF SYMPTOMS WORSENED. THE EVENT DETAILS AND X-RAY WERE REVIEWED BY A VIBRANT MEDICAL ADVISOR, A GASTROENTEROLOGIST, WHO CONCLUDED THAT NO FURTHER ACTION WAS INDICATED. VIBRANT DID NOT ASSESS THE ORIGINAL COMPLAINT INFORMATION AVAILABLE AT THAT TIME AS MEETING MDR REPORTABILITY CRITERIA. THIS REPORT IS SUBMITTED IN RESPONSE TO VOLUNTARY MEDWATCH REPORT MW5188455.