Description of Event or Problem · 0
AS REPORTED TO CUSTOMER RELATIONS VIA CRI OBSERVATION STUDY COMPLAINT FORM:ON (B)(6) 2020 PATIENT UNDERWENT STENT PLACEMENT TO THE RIGHT URETER VIA URETEROSCOPY DUE TO INTRINSIC OBSTRUCTION/STRICTURE. PROCEDURE WAS DONE UNDER FLUOROSCOPY. SITE INDICATED THE PROCEDURE WAS SUCCESSFUL.ON (B)(6) 2021, 138 DAYS INDWELL TIME THE DEVICE WAS REMOVED DUE TO SCHEDULED REPLACEMENT.ON (B)(6) 2022, 336 DAYS INDWELL TIME THE DEVICE WAS ATTEMPTED TO BE REMOVED. SITE INDICATED DEVICE DEFICIENCY DUE TO STENT DISLODGEMENT/MIGRATION. THE SITE STATED: ¿THIS WAS A SCHEDULED REPLACEMENT. HOWEVER, STENT WAS ULTIMATELY UNABLE TO BE REMOVED. DURING THE OPERATION, PER OPERATIVE NOTE ON (B)(6) 2022, FINDING WAS "PROXIMAL MIGRATION OF RESONANCE STENT INTO DISTAL URETER, DESPITE MULTIPLE ATTEMPTS, UNABLE TO BASKET AND REMOVE."ON THE SAME DAY THE SITE REPORTED ADVERSE EVENT OF HYDRONEPHROSIS. TREATMENT INCLUDED STENT REMOVAL.ON (B)(6) 2025 A SECOND ATTEMPT WAS MADE AND SUCCESSFUL REMOVAL WITH DEVICE REPLACEMENT. PER THE SITE: ¿STENT WAS UNABLE TO BE REMOVED ON (B)(6) 2022. IT WAS EXCHANGED ON (B)(6) 2022 AFTER A SECOND ATTEMPT¿.SITE HAS RELATED THE EVENT TO THE RESONANCE METALLIC URETERAL STENT. PER THE OPERATIVE NOTE ON (B)(6) 2022, "THE KIDNEY DEMONSTRATED SEVERE HYDRONEPHROSIS WITH FILLING DEFECTS IN THE RENAL PELVIS CORRESPONDING TO THE EXISTING STENT."THE EVENT WAS NOT RELATED TO ANY COOK ANCILLARY DEVICE, STUDY PROCEDURE AND NO OTHER CONDITION OR CIRCUMSTANCE HAS CAUSED OR CONTRIBUTED TO THIS EVENT.THE SITE REPORTED A DEVICE DEFICIENCY PER THE OPERATIVE NOTE: "PROXIMAL MIGRATION OF RESONANCE STENT INTO DISTAL URETER, DESPITE MULTIPLE ATTEMPTS, UNABLE TO BASKET AND REMOVE."THE SITE STATED THE STENT WAS REPLACED ON (B)(6) 2022 WHICH CONCLUDED THE PATIENT¿S ENROLLMENT IN THE STUDY.ADDITIONAL QUESTIONS ASKED (B)(6) 2025.1. ARE ANY IMAGES AVAILABLE FOR REVIEW? N/A, YES, NO -ANS. NO.2. WHAT WAS THE TARGET LOCATION FOR THE STENT? ANS. RIGHT URETER, WITH THE PROXIMAL CURL IN THE RENAL PELVIS AND DISTAL CURL IN THE BLADDER.3. DID ANYTHING HAVE TO BE REMOVED FROM THE PATIENT? N/A, YES, NO -ANS. YES.4. IF YES, PLEASE SPECIFY:A. WHAT PART OF THE BODY THE DEVICE WAS REMOVED FROM?ANS. RIGHT URETER AND RENAL PELVIS.B. WHAT DEVICE WAS REMOVED?ANS. RIGHT URETER AND RENAL PELVIS.C. WHAT INSTRUMENT WAS USED TO REMOVE IT?ANS. RIGHT URETER AND RENAL PELVIS.5. PLEASE SPECIFY THE STORAGE CONDITIONS OF THE DEVICE AT THE FACILITY, PARTICULARLY THOSE RELATING TO LIGHT AND TEMPERATURE.ANS. UNSPECIFIED/UNKNOWN.6. WHY WAS THE STENT REMOVED? N/A, EXCHANGE, OTHER (IF OTHER, PLEASE DETAIL WHY THE STENT WAS REMOVED)ANS. THIS WAS A SCHEDULED REPLACEMENT. HOWEVER, STENT WAS ULTIMATELY UNABLE TO BE REMOVED. DURING THE OPERATION, PER OPERATIVE NOTE ON (B)(6) 2022, FINDING WAS "PROXIMAL MIGRATION OF RESONANCE STENT INTO DISTAL URETER, DESPITE MULTIPLE ATTEMPTS, UNABLE TO BASKET AND REMOVE." STENT WAS SUCCESSFULLY REMOVED ON (B)(6) 2022.7. IF THE STENT WAS REMOVED WHAT WAS USED TO COMPLETE THE PROCEDURE?ANS. NEW 6FR BY 24CM RESONANCE STENT PLACED UNDER ENDOSCOPIC AND FLUOROSCOPIC GUIDANCE.8. WHAT WAS THE LENGTH OF THE INDEWLL TIME?ANS. 337 DAYS.9. WHAT DISEASE MODE WAS THE PHYSICIAN TRYING TO TREAT?ANS. URETERAL OBSTRUCTION/PSEUDO-OBSTRUCTION RELATED TO REDUNDANT RENAL PELVIS CAUSING IMPAIRED DRAINAGE IN A SOLITARY RIGHT KIDNEY.10. WHAT TYPE AND SIZE WIRE GUIDE WAS USED WITH THE DEVICE?ANS. 0.035 SENSOR WIRE AND A SUPERSTIFF WIRE.11. DID THE DEVICE COME WITH A PIGTAIL STRAIGHTENER? N/A, YES, NO (IF YES, WAS THE PIGTAIL STRAIGHTENER USED? N/A, YES, NO).ANS. UNSPECIFIED/UNKNOWN.12. DID THE USER ATTEMPT TO ATTACH THE STENT TO THE INSERTER BEFORE OR AFTER WIRE GUIDE INSERTION? N/A, BEFORE, AFTERANS. UNSPECIFIED/UNKNOWN.13. DID THE USER ATTEMPT TO ATTACH THE TAPERED END OF THE STENT TO THE INSERTER? N/A, YES, NOANS. UNSPECIFIED/UNKNOWN.14. WAS THE DEVICE ASSEMBLED OUTSIDE OF THE BODY? N/A, YES, NO.ANS. UNSPECIFIED/UNKNOWN.15. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? N/A, YES, NO -ANS. NO.16. WHAT INTERVENTION (IF ANY) WAS REQUIRED? ANS. REMOVAL OF OLD STENT AND PLACEMENT OF NEW STENT.17. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? ANS. N/A, SAME PROCEDURE, ANOTHER DAY -ANOTHER DAY; ATTEMPTED REMOVAL (B)(6) 2022 WHICH WAS UNSUCCESSFUL, SECOND ATTEMPT (B)(6) 2022 SUCCESSFUL.18. 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).ANS. UNSPECIFIED/UNKNOWN.19. HOW OFTEN WAS THE STENT CHECKED DURING THE IN-DWELLING TIME? (WHAT METHOD WAS USED?)ANS. 1 ULTRASOUND WAS PERFORMED. ¿RIGHT: THE RIGHT KIDNEY MEASURES 15.1 X 7 X 6.1 CM AND DEMONSTRATES NORMAL CORTICAL ECHOGENICITY AND NORMAL CONTOUR. THERE IS MILD PELVIECTASIS. THERE IS NO FOCAL RENAL MASS LESION OR SHADOWING STONE. A DOUBLE-J URETERIC STENT EXTENDS FROM THE RENAL PELVIS INTO THE BLADDER LUMEN. LEFT: THE LEFT KIDNEY IS SURGICALLY ABSENT. THE URINARY BLADDER APPEARS UNREMARKABLE FOR DEGREE OF DISTENSION. IMPRESSION: 1. A DOUBLE-J RIGHT URETERIC STENT EXTENDS FROM THE RENAL PELVIS INTO THE BLADDER LUMEN. EVIDENCE OF MILD RIGHT PELVIECTASIS BUT NO FRANK HYDRONEPHROSIS. 2. COMPENSATORY HYPERTROPHY OF THE RIGHT KIDNEY AND SURGICAL ABSENCE OF THE LEFT KIDNEY.¿20. WAS THE PATIENT USING CALCIUM SUPPLEMENTATION?ANS. NO.21. WAS FORCE REQUIRED TO REMOVE THE STENT?ANS. NO.22. WAS ENCRUSTATION EVIDENT ON THE STENT?ANS. NO.23. "ACCORDING TO THE RESONANCE METALLIC URETERAL STENT IFU, THE DEVICE IS INDICATED FOR UP TO O12 MONTHS OF INDWELL TIME. THE COMPLAINT REPORT STATES THAT THE DEVICE WAS REMOVED AFTER 138 DAYS DUE TO 'SCHEDULED REPLACEMENT.' CAN YOU CLARIFY WHY THE DEVICE WAS SCHEDULED FOR REMOVAL AT 138 DAYS, RATHER THAN THE MAXIMUM 12 MONTH INDWELL PERIOD AS PERMITTED BY THE IFU? WAS THERE A CLINICAL OR PROCEDURAL REASON FOR THIS EARLIER REMOVAL?"ANS. UNCLEAR, BUT IN THE INDICATIONS FOR THE PROCEDURE IN THE OP NOTE ON (B)(6) 2021, ¿58-YEAR-OLD MALE WITH SOLITARY RIGHT KIDNEY, INITIALLY PRESENTED WITH RUPTURE OF RIGHT RENAL COLLECTING SYSTEM WITH SIGNIFICANT RETROPERITONEAL URINE EXTRAVASATION WHO WAS MANAGED WITH A RIGHT NEPHROSTOMY TUBE AND SUBSEQUENTLY UNDERWENT DIAGNOSTIC ANTEGRADE/RETROGRADE. ON (B)(6) UNDERWENT ROBOTIC RIGHT PYELOLASTY. STENT WAS REMOVED AFTER 6 WEEKS. SUBSEQUENTLY HAS HAD WORSENING RIGHT FLANK PAIN. LASIX RENAL SCAN SHOWS OBSTRUCTION. CT WITH HYDRO. AKI WITH CR TO 1.5. HE UNDERWENT URETEROSCOPY WHICH NOTED A PATENT ANASTOMOSIS WITH REDUNDANT RENAL PELVIS FLOPPING OVER THE URETER CAUSING A PSEUDO-OBSTRUCTION. A NEPHROSTOMY TUBE WAS PLACED FOR TEMPORARY DRAINAGE OF HIS SOLITARY RIGHT KIDNEY. GIVEN WIDE OPEN ANASTOMOSIS OPTION TO PROCEED WITH REPEAT ANTEGRADE NEPHROSTOGRAM. HOWEVER, STILL DID NOT SHOW PASSAGE OF CONTRAST. HE UNDERWENT A REDUCTION PYELOPLASTY GIVEN THE LARGE REDUNDANT RENAL PELVIS. INTRAOP, WAS NOTED TO HAVE WIDE OPEN PATENT ANASTOMOSIS AS WELL AS PASSAGE OF DYE INTO BLADDER. UNFORTUNATELY, SUBSEQUENT ANTEGRADE SHOWED NO PASSAGE OF CONTRAST. URETEROSCOPY PERFORMED AT PRIOR SHOWED WIDE OPEN ANASTOMOSIS. HE HAD A RESONANCE STENT PLACED AND HAS TOLERATED IT WELL.WE AGREED TO PROCEED WITH CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT URETEROSCOPY, POSSIBLE LASER INCISION OF STRICTURE EXCHANGE OF RIGHT RESONANCE STENT, THE PROCEDURE WAS EXPLAINED IN DETAIL AND THE RISKS/BENEFITS/ALTERNATIVES WERE REVIEWED. I DISCUSSED IN FULL DETAIL ALL THE POSSIBLE COMPLICATIONS, RISK FACTORS, POSSIBLE NEED FOR ADDITIONAL PROCEDURES, RISK OF BLEEDING, RISKS THAT COME WITH ANESTHESIA (INCLUDING HEART ATTACK, STROKE, PULMONARY COMPLICATIONS, OR DEATH), ANTICIPATED RECOVERY TIME, AND I TOOK AMPLE TIME TO ENSURE ALL QUESTIONS WERE ANSWERED TO THE SATISFACTION OF THE PATIENT AND ALL PARTIES PRESENT DURING THIS DISCUSSION.¿