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

Model Number	M00536880
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted to treat a biliary stenosis in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6),2024.During the procedure, when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve.Reportedly, no stent was left inside the patient.The procedure was completed with another advanix pancreatic stent.There was no patient complication reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct during deployment.However, the advanix pancreatic stent instructions for use (ifu) states that, " to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher".However, this step was not followed by the user.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b5 have been updated with the additional information received on december 20, 2024.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted to treat a biliary stenosis in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve.Reportedly, no stent was left inside the patient.The procedure was completed with another advanix pancreatic stent.There was no patient complication reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct during deployment.However, the advanix pancreatic stent instructions for use (ifu) states that, " to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher".However, this step was not followed by the user.No further information has been obtained despite good faith efforts.***additional information received on december 20, 2024**** it was reported that during the procedure, the physician could no longer locate the guidewire in the duodenum.Consequently, the pancreatic stent, along with the guidewire, was removed from the patient.
Additional Manufacturer Narrative
Blocks b5 have been updated with the additional information received on december 20, 2024.Block h6: imdrf device code a0401 captures the reportable event of stent break.H11: an advanix pancreatic stent were received for analysis.Visual examination of the returned device found the stent detached.No other damages were identified on the device.Product analysis confirmed the reported event of stent detached, and the investigation concluded that when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve".Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.A labeling review was performed as per instructions for use (ifu) and it was found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.As per ifu states: "to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher", however, this step wasn't followed by the user.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted to treat a biliary stenosis in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve.Reportedly, no stent was left inside the patient.The procedure was completed with another advanix pancreatic stent.There was no patient complication reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct during deployment.However, the advanix pancreatic stent instructions for use (ifu) states that, " to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher".However, this step was not followed by the user.No further information has been obtained despite good faith efforts.***additional information received on december 20, 2024**** it was reported that during the procedure, the physician could no longer locate the guidewire in the duodenum.Consequently, the pancreatic stent, along with the guidewire, was removed from the patient.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted to treat a biliary stenosis in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve.Reportedly, no stent was left inside the patient.The procedure was completed with another advanix pancreatic stent.There was no patient complication reported as a result of this event.Note: it was reported that the guidewire was in the pancreatic duct during deployment.However, the advanix pancreatic stent instructions for use (ifu) states that, "to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher".However, this step was not followed by the user.No further information has been obtained despite good faith efforts.Additional information received on december 20, 2024: it was reported that during the procedure, the physician could no longer locate the guidewire in the duodenum.Consequently, the pancreatic stent, along with the guidewire, was removed from the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.H11: an advanix pancreatic stent were received for analysis.Visual examination of the returned device found the stent detached.No other damages were identified on the device.Product analysis confirmed the reported event of stent detached, and the investigation concluded that when they began introducing the guidewire into the operating channel, the physician lost the bile duct guide wire.As a result, the physician attempted to remove the stent from the operating channel by pulling it upward.However, the stent broke into half at the biopsy valve".It most likely, procedural factors could have affected the overall performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.A labeling review was performed as per instructions for use (ifu) and it was found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.As per ifu states: "to fully deploy the stent, unlock the guidewire from the boston scientific rx locking device, and completely retract the guidewire into pusher"; however, this step wasn't followed by the user.

• Brand Name: ADVANIX? PANCREATIC STENT
• 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: 21106908
• Report Number: 3005099803-2024-06874
• Device Sequence Number: 7947422
• Product Code: FGE
• UDI-Device Identifier: 08714729856474
• UDI-Public: (01)08714729856474(17)250605(10)32992153
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133700
• 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,Followup,Followup
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2025
• Device Model Number: M00536880
• Device Catalogue Number: M00536880
• Device Lot Number: 0032992153
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 12/20/2024; 02/18/2025; 03/24/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/15/2025; 03/13/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sex: Unknown