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

Model Number	M00534350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(report source): study: boston scientific e7118 endoscopy post market surveillance data collection.Impact code f02 captures the reportable event of death.
Event or Problem Description
It was reported to boston scientific that an advanix rx biliary stent was placed successfully on (b)(6) 2022.On (b)(6) 2022, the patient died.Relation to the stent placement was not specified.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block g2 (report source): study: boston scientific corporation e7118 endoscopy post market surveillance data collection.Block h2 (additional information): block a2, a3, block b5, b7, and block h6 patient code and impact code, have been updated based on the additional information received on february 3, 2023.Block h10: it was initially reported to boston scientific corporation (bsc) that an advanix rx biliary stent was placed successfully on (b)(6), 2022.On (b)(6), 2022, the patient passed away.Relation to the stent placement was not specified at the time of the initial report.On february 3, 2023, additional information was received from the physician clarifying that there was no relationship between the advanix rx biliary stent and the patient death.The patient was on palliative status (ps) and the patient cause of death was lethal evolution of tumoral disease.The sequence of events leading up to the patient death were end of life of tumoral disease with occlusion syndrome and palliative care.Based on all available information, there was no alleged product performance issue with the advanix rx biliary stent and in the physician assessment the stent did not cause or contribute to the patient death.Bsc no longer considers this to be a mdr reportable event.
Event or Problem Description
It was reported to boston scientific that an advanix rx biliary stent was placed successfully on (b)(6), 2022.On (b)(6), 2022, the patient passed away.Relation to the stent placement was not specified.Additional information received on february 3, 2023: the physician clarified that there was no relationship between the advanix rx biliary stent and the patient death.The patient was on palliative status (ps) and the patient cause of death was lethal evolution of tumoral disease.The sequence of events leading up to the patient death were end of life of tumoral disease with occlusion syndrome and palliative care.Additionally, the physician noted that the stent was placed as biliary drainage for metastatic cholangitis, the stent was not explanted prior to the patient death and the patient status at the close of the stent placement procedure was ps 2-3.The patient had a history of adenocarcinoma of the cardia, treated by radiation chemotherapy treatment (rct), surgery and immunotherapy, and prostate adenocarcinoma.

• 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: 16293238
• Report Number: 3005099803-2023-00278
• Device Sequence Number: 6273029
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: 06/05/2024
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0029533169
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• 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: Death
• Patient Age: 63 YR
• Patient Sex: Male