TUMOR STENT DOUBLE LOOP URETERAL STENT KIT

Additional Manufacturer Narrative

THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, CLOGGED STENTS REQUIRING EARLY REPLACEMENT. STENT HAD TOTAL OBSTRUCTION. THE STENTS WERE PLACED ON A SCHEDULED BASIS BUT CHANGED ON AN EMERGENCY BASIS. 1 TO MULTIPLE REHOSPITALIZATIONS PER PATIENT DUE TO ACUTE RENAL FAILURE. EARLY REPLACEMENT OF STENTS UNDER GENERAL OR LOCAL ANESTHESIA IN CANCER PATIENTS. AVERAGE TIME BEFORE OBSTRUCTION WAS OBSERVED WAS 89 DAYS BETWEEN THE PLACEMENT OF THE FIRST CATHETER AND ITS EARLY REPLACEMENT. IMPLANTATIONS WERE MOSTLY FOR BLADDER TUMORS, MOSTLY EXTERNAL COMPRESSION. DEVICE WAS EXPOSED TO UNUSUAL CONDITIONS AND FREE OF ANY VISIBLE DEFECTS UPON OPENING.