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

Model Number	M00534270
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent break.Imdrf impact code f2202 captures the additional endoscopic procedure.
Event or Problem Description
It was reported to boston scientific corporation that a advanix-naviflex biliary stent was to be implanted to treat a common bile duct (cbd) stricture in the papilla of the second portion of the duodenum during a endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.Post procedure, patient returned to the hospital three months after the bile duct stent was installed for its removal.It was discovered that the stent had not been fully removed; a portion of it remained in the common bile duct (cbd).The remaining fragments were subsequently extracted using biopsy forceps.Original device was used to complete the procedure.There were no patient complications reported as a result of this event.The patient status following the procedure was stable.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was implanted to treat a common bile duct (cbd) stricture in the papilla of the second portion of the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2025.Three months post stent placement procedure, the patient returned to the hospital for scheduled removal.During the procedure, it was noted that the stent was incompletely retrieved, with fragments remaining within the common bile duct.The remaining fragments were subsequently extracted using biopsy forceps.There were no patient complications reported as a result of this event.The patient status following the procedure was stable.
Additional Manufacturer Narrative
Blocks a2, b2, b5, e1 and h11 have been corrected.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0406 captures the reportable event of stent break.Block h11: an advanix-naviflex biliary stent and delivery system were returned.During the media analysis, the photo attached showed a stent inside the body; however, the damages in the device are not clear with the picture point of view.During the visual inspection, the returned stent was kinked, stretched and broken.With all the available information, boston scientific concludes that the reported event of stent broken was confirmed.Media analysis included a photo showing the stent in situ; however, the image did not clearly depict the extent of the damage due to its angle.It was reported that the stent appeared broken during removal, with remaining fragments retrieved using biopsy forceps.Device analysis revealed the stent was kinked, stretched, and broken.These conditions may have resulted from the physician's technique during placement, although it cannot be determined whether the damage occurred during initial deployment or was only identified during removal.Additionally, the impact codes of "additional device required" and "endoscopic procedure" were reported, indicating that an extra device and an endoscopic intervention were necessary due to procedural challenges.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22044593
• Report Number: 3005099803-2025-02221
• Device Sequence Number: 18369684
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365(17)260918(10)34958523
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K203162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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 Expiration Date: 09/18/2026
• Device Model Number: M00534270
• Device Catalogue Number: M00534270
• Device Lot Number: 0034958523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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