SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

Additional Manufacturer Narrative

E3 = SR. CLINICAL RISK ADVISOR; (B)(6) MEDICAL DEVICE SAFETY PROGRAM THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

AS REPORTED, THE 'SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT' CONTAINED DEPOSITS/CALCIFICATIONS. THE URETERAL STENT PLACEMENT WAS FOLLOWING KIDNEY TRANSPLANT. THE STENT WAS PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. ULTRASOUND IMAGING DEMONSTRATED INCREASED URETERAL WALL THICKENING. FOLLOWING DEVICE REMOVAL, DEPOSITS/ENCRUSTATION WERE NOTED ON BOTH ENDS OF THE STENT (SEE ATTACHED IMAGE). POST-REMOVAL ULTRASOUNDS CONTINUED TO DEMONSTRATE MILD HYDRONEPHROSIS WITH INTERVAL WORSENING COMPARED TO PRIOR IMAGING, PERSISTENT URETERAL DILATION THROUGHOUT ITS COURSE MEASURING UP TO 9 MM, AND INTERVAL REMOVAL OF THE URETERAL STENT. IMAGING ALSO IDENTIFIED A 6.7 MM NON-MOBILE ECHOGENIC FOCUS WITHIN THE DISTAL URETER DEMONSTRATING TWINKLE ARTIFACT ON COLOR DOPPLER EXAMINATION. THE ECHOGENIC FOCUS APPEARED EMBEDDED WITHIN THE URETERAL WALL AND SURROUNDED BY A HETEROGENEOUS AREA, SUGGESTIVE OF A SMALL CALCULUS WITH SURROUNDING GRANULATION TISSUE. FOLLOWING STENT REMOVAL, THE UROLOGIST NOTED THE STENT TO BE MORE HEAVILY ENCRUSTED THAN EXPECTED. THE DEPOSITS/CALCULUS MATERIAL WERE SUBMITTED FOR STONE ANALYSIS ON A STAT BASIS, WITH RESULTS PENDING AS OF (B)(6) 2026. THE PATIENT SUBSEQUENTLY UNDERWENT SERIAL KIDNEY AND BLADDER ULTRASOUNDS ON (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), AND (B)(6) TO MONITOR PROGRESSION OF HYDRONEPHROSIS AND URETERAL DILATION. ADDITIONALLY, THE PATIENT EXPERIENCED TWO POSTOPERATIVE EPISODES OF UROSEPSIS, AND A NON-OBSTRUCTIVE RENAL CALCULUS REMAINED PRESENT IN THE KIDNEY.