EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

Additional Manufacturer Narrative

SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-2026. DEVICE EVALUATION: THE EVO-22-27-9-D DEVICE OF LOT NUMBER C2285171 INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. TWO PHOTOGRAPHS WERE SUBMITTED WITH THE COMPLAINT REPORTED. THESE PHOTOGRAPHS SHOWED THE OUTER PACKAGING BOX OF THE DEVICE WITH THE DEVICE LABEL INFORMATION. MANUFACTURING RECORDS REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. HISTORICAL DATA REVIEW: THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL REVIEW: IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0053) STATES THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. CLINICAL IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT ANATOMY OR DAMAGE/DIFFICULTY DURING ADVANCEMENT OF THE DEVICE. IT IS POSSIBLE THAT COMPRESSION FROM THE PATIENTS ANATOMY AND ATTEMPTS TO DEPLOY MAY HAVE RESULTED IN A BUILD UP OF PRESSURE, SUBSEQUENTLY LEADING TO THE TRIGGER GETTING JAMMED, AND AS A RESULT THE STENT COULD NOT BE DEPLOYED. WHILE THE PATIENTS ANATOMY WAS NOT DIFFICULT AND AS PER THE USER ¿ NOT MUCH RESISTANCE WAS EXPERIENCED, IF IT WAS IN SOME WAY UNFAVORABLE OR EXERTED STRESS ON THE DEVICE DURING DEPLOYMENT, IT COULD HAVE CONTRIBUTED TO THE BUILD UP OF PRESSURE LEADING TO THE COMPLAINT ISSUE. ANOTHER POSSIBLE ROOT CAUSE COULD BE THAT THE INTRODUCER OF THE DEVICE POSSIBLY KINKED DURING ADVANCEMENT. THE PRESSURE BUILD-UP OF ATTEMPTING TO DEPLOY WITH A POSSIBLE KINKED INTRODUCER, WOULD HAVE BEEN FELT THROUGH TRIGGER RESISTANCE DESCRIBED BY THE CUSTOMER AND THE STENT WOULD NOT BE DEPLOYED. HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY OF INVESTIGATION: ACCORDING TO THE INITIAL COMPLAINT REPORTED, THE EVO-22-27-9-D DEVICE OF LOT NUMBER C2285171 DID NOT COME OUT OF THE CATHETER AS THE TRIGGER MECHANISM WAS NOT MOVING/WORKING, IT GOT JAMMED. CONFIRMED QUANTITY OF 01 X USED DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THEY WERE ABLE TO REMOVE THE COMPLAINT DEVICE AND INSERT ANOTHER EVOLUTION DEVICE. INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE PATIENTS ANATOMY AND/OR ADVANCEMENT OF THE DEVICE.

Description of Event or Problem

SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-FEB-2026.

Additional Manufacturer Narrative

E1, F5 - PHONE NUMBER: (B)(6). INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

THE STENT DIDNOT COME OUT OF THE CATHETER, AS THE TRIGGER MECHANISM WAS NOT MOVING / WORKING, IT GOT JAMMED. SO IT WAS REOMOVED AND THE CASE WAS COMPLETED WITH ANOTHER OF ECO-D STENT. QUERY REPLY_12DEC2025 WAS THE PRODUCT INSPECTED FOR DAMAGE BEFORE USE? (KINKS ETC), NOTHING WAS NOTED VISIBLY. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? 0.035 GUIDE WIRE OF COMPETITOR MAKE, WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY ? N/A. IF ALTERED PLEASE INDICATE THE PROCEDURE TYPE N/A. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? YES. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? N/A, YES, NO, THIS QUESTION IS IRRELEVANT. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? DUODENUM. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? NOTHING MUCH EXPERIENCED. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? ALL SOP¿S WERE FOLLOWED AS PER DIRECTIONS OF USE. WAS THE YELLOW MARKER KEPT IN VIEW DURING ATTEMPTED DEPLOYMENT? YES. DID ANY PART OF THE STENT CONTACT THE PATIENT'S ANATOMY WHEN THE COMPLAINT OCCURRED? YES. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DEVICE? NOTHING WAS NOTED VISIBLY.