Description of Event or Problem · 0
AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM: ON (B)(6) 2019 THE DEVICE WAS PLACED DUE TO STRICTURE VIA ENDOUROLOGICAL URETEROSCOPY. PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY. PROCEDURE WAS SUCCESSFUL. ON (B)(6) 2020, 190 DAYS POST PROCEDURE, SITE REPORTED A URINARY TRACT INFECTION (UTI) WITH TREATMENT OF ANTIBIOTICS AND ¿REPLACEMENT OF DEVICE ON (B)(6) 2020 EARLIER THAN PLANNED.¿ THE SITE RELATED TO A RESONANCE METALLIC URETERAL STENT SET PER THE SITE. THE SITE REPORTED ¿PER DOCTOR'S NOTE, "THE RESONANCE STENT WAS CHANGED PREMATURELY DUE TO INFECTION WHICH MAY HAVE BEEN THE RESULT OF THE STENT'S ENCRUSTATION". THE EVENT WAS CONSIDERED NOT RELATED TO THE STUDY PROCEDURE. THE SITE NOTED THAT NO OTHER CONDITION OR CIRCUMSTANCE CAUSE OR CONTRIBUTED TO THIS EVENT. THE SITE REPORTED THAT A DEVICE DEFICIENCY DID OCCUR STATING ¿STENT WAS ENCRUSTED.¿ ON (B)(6) 2020, 201 DAYS INDWELL TIME, THE PATIENT HAD A SUCCESSFUL STENT REPLACEMENT WAS PERFORMED DUE TO STENT ENCRUSTATION. SITE NOTED ¿PER OPERATIVE NOTE ON (B)(6) 2020, "AN ENCRUSTED RESONANCE STENT EXTRUDING FROM THE LEFT UO WITH SIGNIFICANT EDEMA AROUND THIS UO". ON (B)(6) 2021, 206 DAYS INDWELL TIME, SITE NOTED ¿DEATH¿ AND SITE RESPONDED TO QUERY ¿PATIENT PASSED FROM COVID, NOT DEVICE RELATED¿ PATIENT EXITED STUDY, SITE REPORTED DEATH DUE TO COVID. 1. ARE ANY IMAGES AVAILABLE FOR REVIEW? N/A, YES, NO -NO IMAGES AVAILABLE. 2. WHAT WAS THE TARGET LOCATION FOR THE STENT? THE STENT WAS TARGETED FOR PLACEMENT IN THE LEFT URETER, WITH THE UPPER CURL POSITIONED IN THE UPPER POLE CALYX OF THE LEFT KIDNEY AND THE DISTAL END CURLED IN THE BLADDER. 3. DID ANYTHING HAVE TO BE REMOVED FROM THE PATIENT? N/A, YES, NO -YES. 4. IF YES, PLEASE SPECIFY: A. WHAT PART OF THE BODY THE DEVICE WAS REMOVED FROM? THE LEFT URETER AND BLADDER. B. WHAT DEVICE WAS REMOVED? THE PREVIOUS STENT. C. WHAT INSTRUMENT WAS USED TO REMOVE IT? A SUPER-STIFF WIRE WAS FIRST PLACED, THEN THE STENT WAS PULLED OUT, IMPLIED WITH USE OF WIRE AND CYSTOSCOPE TOOLS. 5. PLEASE SPECIFY THE STORAGE CONDITIONS OF THE DEVICE AT THE FACILITY, PARTICULARLY THOSE RELATING TO LIGHT AND TEMPERATURE. UNSPECIFIED/UNKNOWN. 6. IF THE STENT WAS REMOVED WHAT WAS USED TO COMPLETE THE PROCEDURE? UNSPECIFIED, BUT A NEW 26 CM RESONANCE STENT WAS DEPLOYED OVER A SUPER-STIFF WIRE AFTER REMOVAL OF THE PREVIOUS STENT. 7. WHAT DISEASE MODE WAS THE PHYSICIAN TRYING TO TREAT? URETERAL OBSTRUCTION LIKELY RELATED TO INTRAVESICAL PROSTATE ENLARGEMENT AND ENCRUSTATION OF THE PRIOR STENT; TREATMENT AIMED TO RELIEVE OBSTRUCTION AND MAINTAIN URETERAL PATENCY. 8. WHAT TYPE AND SIZE WIRE GUIDE WAS USED WITH THE DEVICE? INITIALLY, A GLIDEWIRE WAS USED TO PASS THE URETERAL OBSTRUCTION; LATER EXCHANGED FOR A SUPER-STIFF WIRE FOR STENT PLACEMENT. 9. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO 10. WHAT INTERVENTION (IF ANY) WAS REQUIRED? CYSTOLITHOLAPAXY TO REMOVE ENCRUSTED PORTIONS OF THE OLD STENT, WIRE-GUIDED STENT REMOVAL, AND REPLACEMENT WITH A NEW RESONANCE STENT. 11. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY -SAME PROCEDURE 12. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G., KINK)? N/A, YES, NO (IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED) THE STENT WAS NOTED TO BE "MILDLY TO MODERATELY ENCRUSTED," BUT NO KINKS OR OTHER MECHANICAL DEFECTS WERE DESCRIBED. 13. HOW OFTEN WAS THE STENT CHECKED DURING THE IN-DWELLING TIME? (WHAT METHOD WAS USED?) IN THE INDWELL TIME OF 201 DAYS, THE FOLLOWING IMAGING WERE DONE: ¿(B)(6) 2020 CT WITHOUT CONTRAST: NO EVIDENCE OF LOCAL RECURRENCE IN RIGHT NEPHRECTOMY SITE, LEFT STENT IN PLACE WITHOUT HYDRONEPHROSIS, (B)(6) 2020: CT; LEFT JJ STENT IN PLACE. MILD LEFT PELVIECTASIS AND URETERECTASIS. NED. (B)(6) 2020: FLUORO - LEFT RESONANCE STENT REPLACED.¿ 14. WAS THE PATIENT USING CALCIUM SUPPLEMENTATION? NO. 15. WAS FORCE REQUIRED TO REMOVE THE STENT? NO.