MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Pain (1994); Sepsis (2067); Vomiting (2144); Cholangitis (4821)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event and same patient (mfr report (b)(4).It was reported to boston scientific that two advanix biliary stents were successfully placed as stent exchange during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2023.From (b)(6) 2023, at an outside hospital (osh), the patient experienced acute right upper quadrant (ruq) pain, emesis (vomiting), chills and fever of 100.7 degrees, concerning for cholangitis.The patient was hospitalized and was given levofloxacin, metronidazole, flagyl, dapto, and tylenol as a treatment for cholangitis, fever, and pain; and was also administered with intravenous lactated ringer's (lr) solution for hydration.From (b)(6) 2023, it was reported that the cholangitis was growing and was vancomycin-resistant enterococci complicated by sepsis, and post ercp pancreatitis with hepatic abscess due to the procedure performed on (b)(6) 2023.From (b)(6) 2023, the patient experienced abdominal pain in the setting of transaminitis with obstruction.The patient was discharged with ceftriaxone and metronidazole as discharged medication.The fever seemed to be better at the time the patient was discharged.On (b)(6) 2023, another procedure was performed to remove the implanted stents (the subject of this report (b)(4), and a wallflex biliary stent was placed to successfully complete the procedure.The patient was reported to have pancreatic cancer and pain was ongoing.In the physician's assessment, there was a chance that the patient's adverse event was due to the stent change and the cholangitis was concerning for sepsis.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient's year of birth was 1945.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: study: e7118 boston scientific corporation endoscopy post market surveillance data collection.Block h6: imdrf patient code (b)(6) captures the reportable event of cholangitis.Imdrf patient code (b)(6) captures the reportable event of abscess.Imdrf patient code (b)(6) captures the reportable event of sepsis.Imdrf patient code (b)(6) captures the reportable event of pain.Imdrf impact code (b)(6) captures the reportable event of unexpected medical intervention.Imdrf impact code (b)(6) captures the reportable event of medication required.Imdrf impact code (b)(6) is being used to capture the reportable event of hospitalization or prolonged hospitalization.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17612899
• Report Number: 3005099803-2023-04471
• Device Sequence Number: 15111176
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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: M00534330
• Device Catalogue Number: 3433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown