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Patient 1
(B)(4). PROBLEM STATEMENT: STENT DISINTEGRATED. DURING A CONTROLLING, THE PHYSICIAN FIND A DISINTEGRATED STENT, IN THE ORIGINAL POSITION. WE EXPLANT THE STENT IN 20 PARTS AND IMPLANT A NEW ONE. DEVICE EVALUATION: THE STENT IN RELATION TO THE EVO COMPLAINT DEVICE WAS RETURNED TO CIRL ON THE 14 AUG 2018. NO PACKAGING WAS RETURNED, SO RPN AND LOT NUMBER OF RETURNED STENT CANNOT BE CONFIRMED. THE STENT WAS DECONTAMINATED BUT WAS UNABLE TO BE EVALUATED DUE TO ITS RETURNED DISINTEGRATED STATE. IT WAS NOTED THAT THE RETURNED STENT WAS RETURNED IN MANY PIECES AND THIS CONFIRMS THE COMPLAINT OF STENT DISINTEGRATED. THE FAILURE OF DEVICE WAS ALSO VERIFIED IN THE IMAGES RECEIVED FROM THE CUSTOMER, THE STENT CAN BE SEEN TO BE DISINTEGRATED IN NUMEROUS PIECES WHILST STILL IN THE PATIENT. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED BY THE COOK REPRESENTATIVE AND THE RESPONSES WERE RECEIVED AS BELOW: AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) AFTER 2 MONTH OF IMPLANTATION WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? OLYMPUS 3,7 MM. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? MET-35-480. DID ANY PART OF THE STENT CONTACT THE PATIENT?S ANATOMY WHEN THE COMPLAINT OCCURRED? YES, THE COMPLETE STENT HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? 2 MONTH. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? AFTER 2 MONTH, WAS THE FIRST EVALUATION STRICTURE INFORMATION: WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? 9 CM, 10 MM. WHERE WAS THE STRICTURE LOCATED IN THE BODY? DUODENAL. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? NO. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? NO. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? NO. QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? YES. WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? IF YES, AT WHAT POINT? NO. QUESTIONS RELATED TO DURING INTRODUCER WITHDRAWAL: ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? YES. QUESTIONS RELATED TO DURING STENT REPOSITIONING/REMOVAL: WHAT INSTRUMENT WAS USED FOR STENT REPOSITIONING / REMOVAL? FORCEPS, SNARE. NOT ON THE FIRST IMPLANT. WAS THE LASSO (SUTURE) LOOP USED DURING REPOSITIONING / REMOVAL? A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT?S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: FIVE ENDOSCOPIC IMAGES, ALONG WITH A COMPLAINT REPORT, WERE SUBMITTED FOR REVIEW. FIVE ENDOSCOPIC IMAGES DEMONSTRATED A COOK EVOLUTION DUODENAL STENT WITHIN WHAT APPEARS TO BE THE DUODENUM. SEVERAL IMAGES OF THE STENT DEMONSTRATE DISRUPTION OF THE NORMAL STENT LATTICE WITH SEVERAL FREE ENDS OF DISPLACED METALLIC COMPONENTS OF THE STENT. THERE IS A SIGNIFICANT AMOUNT OF FOOD DEBRIS CAUGHT WITHIN THE STENT LATTICE AS WELL AS WHAT APPEARS TO BE MALIGNANT OVERGROWTH INVOLVING APPROXIMATELY 75% OF THE LUMEN OF THE DUODENUM. THERE IS MINIMAL TISSUE INGROWTH SEEN WITHIN THE PORTION OF THE STENT LATTICE THAT IS INTACT. THERE ARE NO FLUOROSCOPIC IMAGES SUBMITTED FOR REVIEW. IMPRESSION: PER THE COMPLAINT REPORT, THE COOK EVOLUTION DUODENAL STENT WAS PLACED FOR A 9 CM LONG STRICTURE WITH A DIAMETER OF 10 MM, INVOLVING THE DUODENUM. ALTHOUGH NOT SPECIFIED WITHIN THE COMPLAINT REPORT, THIS STRICTURE IS PRESUMED TO BE A MALIGNANT STRICTURE AS THE IFU FOR THE COOK EVOLUTION DUODENAL STENT IS APPROVED FOR PALLIATIVE USE ONLY. THE INITIAL PLACEMENT IMAGES WERE NOT SUBMITTED FOR REVIEW. THE 5 ENDOSCOPIC IMAGES SUBMITTED ARE REPORTEDLY ACQUIRED 2 MONTHS AFTER IMPLANTATION OF THE COOK EVOLUTION DUODENAL STENT. THEY DEMONSTRATE MINIMAL MUCOSAL INGROWTH THROUGH THE PORTION OF THE STENT LATTICE THAT APPEARS MAINTAINED. THERE ARE SEVERAL IMAGES DEMONSTRATING A DISORGANIZED APPEARANCE TO THE STENT LATTICE WITH SEVERAL FREE ENDS OF THE STENT, INDICATING STENT FRACTURE HAD OCCURRED. GIVEN THE STENT IS CONSTRUCTED OUT OF A SINGLE WOVEN NITINOL WIRE, ONE FRACTURE CAN RESULT IN THE STENT UNWINDING AND BECOME VERY DISORGANIZED IN APPEARANCE. THERE IS NOTHING INCLUDED ON THE IMAGES THAT WOULD DEMONSTRATE DIRECT CORRELATION WITH INCREASED RISK OF STENT FRACTURE. THE COMPLAINT REPORT STATES THAT THE STENT WAS EVALUATED FOR KINKS OR DAMAGE BEFORE USE, HOWEVER, WITHOUT THE FLUOROSCOPIC...