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

Model Number	M00534240
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2023-06357 for the associated device information.It was reported to boston scientific corporation that two advanix-naviflex rx biliary stents were implanted in the right and left hepatic ducts to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.On november 2, 2023, a day post-stent placement, the patient experienced pain.Imaging was performed, and it was noted that one stent (the subject of this report) migrated and perforated the duodenum, and the other stent (the subject of mfr.Report #3005099803-2023-06357) also migrated.On (b)(6) 2023, another procedure was performed.The stents were removed using rat-tooth forceps, and the perforation was closed using an ovesco clip.No additional stents were implanted in place of the migrated stents.In the physician's assessment, the patient's complication is related to the device and procedure.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f23 captures the reportable event of another procedure performed to remove the stent and address the perforation.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf impact code f23 captures the reportable event of another procedure performed to remove the stent and address the perforation.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2023-06356 and 3005099803-2023-06357 for the associated device information.It was reported to boston scientific corporation that two advanix-naviflex rx biliary stents were implanted in the right and left hepatic ducts to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.On (b)(6) 2023, a day post-stent placement, the patient experienced pain.Imaging was performed, and it was noted that one stent (the subject of this report) migrated and perforated the duodenum, and the other stent (the subject of mfr.Report #3005099803-2023-06357) also migrated.On (b)(6) 2023, another procedure was performed.The stents were removed using rat-tooth forceps, and the perforation was closed using an ovesco clip.No additional stents were implanted in place of the migrated stents.In the physician's assessment, the patient's complication is related to the device and procedure.The patient's condition at the conclusion of the procedure was reported to be fully recovered.

• 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: 18247193
• Report Number: 3005099803-2023-06356
• Device Sequence Number: 6571976
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: 08714729787334
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534240
• Device Catalogue Number: 3424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/12/2023
• 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
• Patient Sex: Unknown