MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.The literature is attached for additional information.
Event or Problem Description
Olympus reviewed the following literature titled " short and long outcomes of endoscopic bilateral metal stent placement for malignant hilar biliary obstruction: tertiary care oncology centre experience." literature summary a retrospective study assessed the short and long-term outcomes of patients undergoing self-expanding metal stents (sems) and bilateral self-expanding metal stents (sems) placement for complex hilar blocks.A total of 43 patients were included with a mean age of 54.9 years with 51.2% of females.Median charlson comorbidity index was 7 with 21 (48.8%) having underlying comorbidities, indicating a suspected 10-year survival rate of 0.01%.Technical success was 95.3% of patients and functional success was 95.1% of patients.On cholangiogram, 26 (60.4%) had bismuth type ii block, 12 (27.8%) had type iiia/b, and 5 (11.6%) had type iv block.One patient had delayed resolution of jaundice after stent placement and in another patient, mortality occurred within 30 days, which precluded the assessment of functional success.Normalization of bilirubin occurred in 35 patients who further received tumor-directed therapy.Complications were managed conservatively.The median hospitalization days were five days (2¿31 days) and the median stent patency was 137 days (8¿790 days).The median overall survival was 153 days.Thus, the study concluded that endoscopic bilateral sems in complex malignant hilar obstruction has good outcomes in the form of technical success, functional success, and stent patency.Complications included post ercp pancreatitis in 6/43 (13.9%) patients, cholangitis was seen in 3/43 (6.9%) patients and post procedure hypertension in one patient (2.32%).Pancreatitis was mild in all cases.All complications were managed conservatively.Post-procedure 30-day mortality was seen in one patient due to pulmonary thromboembolism.Post-procedure hospitalization days was median five days (2¿31 days).Median stent patency was 137 days (range 8¿790 days, iqr 80¿214 days).Delayed re-intervention in the form of either ercp or ptbd for stent block was required in 4/43 patients (9.3%) after mean 295.7 days.Of those who needed reintervention, two patients had type ii block and two had type iii/iv block.No difference was seen in stent patency between those having type ii block or more advanced block (iii/iv) (p = 0.90).Median survival in our cohort was 153 days (range 8¿870 days; iqr 108¿234 days).Type of adverse events/number of patients: death (1, related to a pulmonary thromboembolism within 30 days of the procedure), death (42, median survival was 153 days (range 8¿870 days).This literature article requires 6 reports.The related patient identifiers are as follows: -(b)(6) (tjf-150) for all adverse events, -(b)(6) (tjf-q180v) for all adverse events, -(b)(6) (kd-v411m-0720) for all adverse events, -(b)(6) (tjf-150) for all deaths, -(b)(6) (tjf-q180v) for all deaths, -(b)(6) (kd-v411m-0720) for all deaths.This medical device report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17803228
• Report Number: 9614641-2023-01381
• Device Sequence Number: 15249697
• Product Code: KNS
• UDI-Device Identifier: 04953170184017
• UDI-Public: 04953170184017
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KD-V411M-0720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS G-240-2527A; OLYMPUS TJF-150; OLYMPUS TJF-Q180V
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown