FDA Adverse Event Injury Summary report: N

VIBRANT

MDR report key: 20686598 · Received November 13, 2024

Report

Report Number
MW5162502
Event Type
Injury
Date Received
November 13, 2024
Date of Event
August 8, 2024
Report Date
November 8, 2024
Manufacturer
VIBRANT LTD
Product Code
QTN
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

I BELIEVE THIS IS THE FIRST REPORTED BOWEL/STERCORAL PERFORATION ASSOCIATED WITH VIBRANT PILL ADMINISTRATION FOR CHRONIC CONSTIPATION. THIS PATIENT HAS HISTORY OF CHRONIC PAIN WITH MULTIPLE BACK SURGERIES, INTRATHECAL PUMPS, OPIATE INDUCED CONSTIPATION WHO PRESENTED BY AMBULANCE UNRESPONSIVE. HE WAS ADMITTED TO MEDICAL ICU FOR SEPTIC SHOCK OF UNKNOWN ETIOLOGY AND INTUBATED FOR AIRWAY PROTECTION. HE HAD BEEN ON MULTIPLE REGIMENS FOR HIS CHRONIC CONSTIPATION INCLUDING SEVERAL MOTILITY AGENTS AS WELL AS BEING STARTED ON VIBRATING PILL THERAPY AS AN OUTPATIENT WITH BRAND NAME VIBRANT. PER OUTPATIENT NOTES, HE HAD BEEN STARTED ON THESE VIBRATING PILLS 2 MONTHS PRIOR TO ADMISSION AND HE APPARENTLY HAD NOT PASSED ANY OF THE PILLS THAT HE TOOK AS OF YET DESPITE 2 MONTHS OF WAITING. THERE WERE NUMEROUS 10-15 NON-OBSTRUCTING METALLIC FOREIGN BODIES SEEN ON CT ABDOMEN/PELVIS, CONCENTRATED IN THE SPLENIC FLEXURE AND DESCENDING COLON. COLONOSCOPY WAS INITIALLY DEFERRED DUE TO INSTABILITY. HE HAD BEEN MANAGED IN ICU, WEANED OFF PRESSORS, AND HAD A TRACHEOSTOMY, THEN DOWNGRADED TO STEP DOWN UNIT. HE ALSO WAS STARTED ON TOTAL PARENTERAL NUTRITION BECAUSE HE COULD NOT TOLERATE TUBE FEEDS DUE TO VOMITING. REPEAT IMAGING SHOWED VIRTUALLY NO TRANSIT OF THE METALLIC FOREIGN BODIES FROM ORIGINAL LOCATION. HE BECAME ACUTELY ALTERED AND REPEAT IMAGING SHOWED PNEUMATOSIS INTESTINALIS OF THE DESCENDING COLON WITH CONTAINED PERFORATION WITH AIR FLUID LEVEL SURROUNDING DESCENDING COLON. HE HAD MELENA AND SUBSEQUENT COLONOSCOPY SHOWING NONBLEEDING ULCERS. HE WAS IN SHOCK AND REQUIRED VASOPRESSORS AND TRANSFERRED BACK INTO ICU. HE WAS TAKEN TO THE OR FOR EXPLORATORY LAPAROTOMY WHERE IT WAS FOUND THAT HE HAD EXTENSIVE FECULENT PERITONITIS, NECROSIS OF LARGE BOWEL FROM RIGHT TRANSVERSE COLON TO PROXIMAL SIGMOID COLON, AS WELL AS SOME PARTS OF SMALL BOWEL. THE NECROTIC BOWEL WAS RESECTED, BLIND POUCHES WERE SUTURED, ABDOMEN LEFT OPEN WITH PLANS TO RETURN TO OR THE NEXT DAY. UPON RETURNING TO OR, THE SUTURES OF BLIND POUCH OF TRANSVERSE COLON HAD RUPTURED DUE TO BOWEL EDEMA AND HE HAD SPILLAGE OF PURULENT ENTERIC CONTENTS INTO HIS ABDOMEN. THE ABDOMEN WAS IRRIGATED COPIOUSLY, ILEOSTOMY WAS CREATED, AND SEVERAL DRAINS LEFT IN. HIS HOSPITAL COURSE WAS ALSO COMPLICATED BY PELVIC ABSCESS STATUS POST CT GUIDED DRAIN PLACEMENT BY INTERVENTIONAL RADIOLOGY. HE ALSO HAD A LOWER EXTREMITY DEEP VEIN THROMBOSIS FOR WHICH HE RECEIVED AN IVC FILTER. HE WAS EVENTUALLY ABLE TO BE RESTARTED ON TUBE FEEDS AND WAS DISCHARGED TO LTAC FOR FURTHER CARE. PNEUMATOSIS INTESTINALIS OF DESCENDING COLON WITH CONTAINED PERFORATION SURROUNDING DESCENDING COLON.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2112754 VIBRANT ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION QTN VIBRANT LTD DEN210052

Patients

Seq Age Sex Outcome Treatment
1 Male Congenital Anomaly| O| H| L| R