EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

Additional Manufacturer Narrative

INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

Description of Event or Problem

DURING EXPANSION, SOMETHING CRACKED IN THE HANDLE AND THE PROSTHESIS DID NOT OPEN. AFTER STARTING TO EXPAND THE STENT USING THE TRIGGER, A CRACKING SOUND WAS HEARD AND THE STENT STOPPED RESPONDING TO THE TRIGGER. IS THE COMPLAINT DEVICE AVAILABLE FOR RETURN TO CIRL? IF SO, PLEASE PROVIDE TRACKING NUMBER DETAILS. YES, DHL (B)(4). ARE THERE ANY IMAGES/VIDEOS OF THE COMPLAINT DEVICE/PROCEDURE AVAILABLE? NO. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? PENTAX 4.2 MM. WHAT WAS THE TARGET LOCATION? SIGMOID COLON. WHAT WAS THE DIAMETER OF THE WIRE GUIDE USED? COOK MEDICAL-METII-35-480. WAS THE ZIP PORT FACING UPWARDS AND SLIGHTLY CURVED WHEN BACKLOADING THE WIRE GUIDE? YES. DID THE PATIENT EXHIBIT DIFFICULT ANATOMY (N/A, TORTUOUS, ALTERED)? NO. WAS PRE-DILATION/POST-DILATION PERFORMED? NO. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED?) NO RESISTANCE. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LOCATION? (IF RESISTANCE WAS FELT HOW DID THE PHYSICIAN DEAL WITH THE RESISTANCE ENCOUNTERED?) NONE. WAS A STENT PREVIOUSLY PLACED AT THE SAME OR ADJACENT LOCATION? (IF YES, WAS THE COMPLAINT STENT PLACED IN THE STENT THAT/WAS ALREADY IN SITU?) NO. WHAT WAS THE POSITION OF THE ELEVATOR DURING ADVANCEMENT/DEPLOYMENT/REMOVAL? OPEN. WERE ANY OTHER DEFECTS (OTHER THAN THE COMPLAINT ISSUE) OBSERVED ON THE DELIVERY SYSTEM (E.G., KINKS) PRIOR TO RETURN? NO HOW WAS THE PROCEDURE COMPLETED? (IE. ANOTHER DEVICE, SCHEDULED FOR ANOTHER DAY) ANOTHER STENT WAS USED.