CANNULA

Description of Event or Problem

OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UTILITY AND SAFETY OF ENDOSCOPIC PAPILLARY BALLOON DILATION WITH SMALL-INCISION SPHINCTEROTOMY FOR SMALL BILE DUCT STONES: A RANDOMIZED CONTROLLED TRIAL.¿ BACKGROUND: ENDOSCOPIC SPHINCTEROTOMY (ES) FOR BILE DUCT STONES (BDS) CAN CAUSE BASKET IMPACTION WITH STONE, COMPLICATING THE PROCEDURE. IN THIS STUDY, WE EVALUATED THE UTILITY AND SAFETY OF SMALL INCISION ES COMBINED WITH ENDOSCOPIC PAPILLARY BALLOON DILATION (SES + EPBD) (BALLOON DILATED UP TO THE STONE SIZE), COMPARED WITH ES ALONE FOR BDS <12 MM. METHODS: THE PRIMARY ENDPOINT WAS THE FREQUENCY OF MECHANICAL LITHOTRIPSY (ML), INDICATING THE RISK OF BASKET IMPACTION WITH STONE; HOWEVER, THE SECONDARY ENDPOINTS WERE PROCEDURE TIME, SUCCESSFUL STONE REMOVAL, AND EARLY ADVERSE EVENTS. RESULTS: A TOTAL OF 100 PATIENTS WERE RANDOMIZED INTO THE ES AND SES + EPBD GROUPS (N = 50 FOR EACH). SIGNIFICANTLY FEWER CASES REQUIRED ML (20.0% VS. 4.0%, P= .028) IN THE SES + EPBD GROUP. THE MAXIMUM SHORT-AXIS DIAMETER OF THE STONES IN ALL PATIENTS REQUIRING ML IN THE ES GROUP RANGED FROM 8 TO 11 MM. THE MEDIAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER (18.5 MIN VS. 17 MIN, P=.047) IN THE SES + EPBD GROUP. BOTH GROUPS SHOWED SIMILAR FREQUENCIES OF SUCCESSFUL STONE REMOVAL IN ONE SESSION (88.0%V S. 98.0%,P = .112) AND EARLY ADVERSE EVENTS (4.0%V S. 2.0%,P = .62). ONE PATIENT EXPERIENCED MILD PANCREATITIS, WHICH WAS MANAGED WITH CONSERVATIVE TREATMENT. ONE PATIENT EXPERIENCED POSTPROCEDURAL BLEEDING THAT WAS MODERATE AND LED TO A REDUCTION IN THE PATIENT'S HEMOGLOBIN LEVEL (FROM 17.2 TO 8.9 G/DL) OCCURRING TWO DAYS AFTER THE RESUMPTION OF EDOXABAN FOR ATRIAL FIBRILLATION ON THE SECOND POSTPROCEDURAL DAY. EMERGENCY ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC) REVEALED HEMOBILIA WITHOUT ACTIVE BLEEDING, AND A PLASTIC STENT WAS DEPLOYED. CONCLUSION: IN CASES OF SMALL BDS, SES + EPBD EXHIBITS A LOW FREQUENCY OF ML, WHICH SHORTENS PROCEDURE TIME AND PREVENTS BASKET IMPACTION WITH STONES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: INTRAPROCEDURAL BLEEDING (N=1) EVENT2: POSTPROCEDURAL BLEEDING (N=1) EVENT3: PANCREATITIS (N=1) EVENT4: CHOLANGITIS (N=1).

Additional Manufacturer Narrative

THE REPORTS OF THE FOLLOWING PATIENT IDENTIFIERS ARE LINKED: (B)(6). E1-FACILITY NAME: (B)(6). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE BUT WERE UNSUCCESSFUL. . THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST PROBABLE CAUSE WAS NOT ESTABLISHED; THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.