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

Model Number	M00534350
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf patient code e0506 captures the reportable patient complication of major hemorrhage.Imdrf impact code f23 captures the unexpected medical intervention performed.Imdrf impact code f08 captures the prolonged hospitalization of the patient.Imdrf impact code f2301 captures the additional devices required to remove the stent and close the perforation.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded duodnal bend stent was implanted in the duodenum to treat a malignant common bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During an emergent patient follow-up on (b)(6), 2023, an esophagogastroduodenoscopy (egd) procedure was performed to assess the patient's upper gastrointestinal (gi) bleeding, and it was confirmed that the advanix rx stent had migrated and perforated the distal side of the duodenal wall, which caused a perforation.Computed tomography (ct) imaging was taken, and the stent was removed using forceps.The perforation was closed with a non-boston scientific clip.The patient was reported to have been admitted to the hospital beyond the standard days of care and has not been discharged but is expected to fully recover.

• 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: 18303970
• Report Number: 3005099803-2023-06614
• Device Sequence Number: 12328920
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• 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
• Report Date (Section B): 12/11/2023

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: M00534350
• Device Catalogue Number: 3435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• 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; Other; Hospitalization
• Patient Sex: Unknown