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

Model Number	M00534330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Stenosis (4066)
Health Effect - Clinical Codes	Abscess (1690); Fever (1858); Pain (1994); Sepsis (2067); Vomiting (2144); Cholangitis (4821)
Date of Event	03/28/2023
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 #3005099803-2023-04102.It was reported to boston scientific that two advanix biliary stents were successfully placed during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6), 2023.On (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 degree, concerning for cholangitis.The patient was hospitalized and was given levofloxacin, metronidazole, flagyl, dapto and tylenol as treatment for cholangitis, fever and pain; and was also administered with intravenous lactated ringer's (lr) solution for hydration.On (b)(6), 2023, another ercp procedure was performed to remove the previously implanted stents (the subject of this report and report (b)(4)).Another two advanix biliary stents were implanted in this procedure as stent exchange.On (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.On (b)(6), 2023, the patient experienced abdominal pain in 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 and a wallflex biliary stent was placed to successfully complete the procedure.The patient was reported to have 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 g2: study: e7118 boston scientific corporation endoscopy post market surveillance data collection.Block h6: imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e172001 captures the reportable event of abscess.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event and same patient (mfr report #3005099803-2023-04102 and mfr.Report #3005099803-2023-04103).It was reported to boston scientific that two advanix biliary stents were successfully placed during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2023.On (b)(6) 2023, at (b)(6) hospital (osh), the patient experienced acute right upper quadrant (ruq) pain, emesis (vomiting), chills and fever of 100.7 degree, concerning for cholangitis.The patient was hospitalized and was given levofloxacin, metronidazole, flagyl, dapto and tylenol as treatment for cholangitis, fever and pain; and was also administered with intravenous lactated ringer's (lr) solution for hydration.On (b)(6) 2023, another ercp procedure was performed to remove the previously implanted stents (the subject of this report and report #3005099803-2023-04102).Another two advanix biliary stents were implanted in this procedure as stent exchange.On (b)(6) to (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.On (b)(6) to (b)(6) 2023, the patient experienced abdominal pain in 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 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 information was received, on august 07, 2023, stating that the two advanix biliary stents implanted on (b)(6) 2023, were found to be obstructed.The obstructed stents were retrieved with a snare.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient's year of birth was (b)(6).Block g2: study: e7118 boston scientific corporation endoscopy post market surveillance data collection.Block h6: imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e172001 captures the reportable event of abscess.Imdrf patient code e0306 captures the reportable event of sepsis.Imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Imdrf device code a0106 captures the reportable event of stent obstruction within device.Block h11: block b5 and block h6 have been updated based on additional information received august 07, 2023.

• 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: 17463602
• Report Number: 3005099803-2023-04103
• Device Sequence Number: 7106145
• 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,Followup
• Report Date (Section B): 09/01/2023

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 Expiration Date: 02/20/2025
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0031092587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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