MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570360
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Migration (4003); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f2301 captures the reportable event of additional deviuce required.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex fully covered biliary rmv stent was implanted in the distal bile duct for 2 months to relieve biliary obstruction on (b)(6) 2024.On (b)(6) 2024, a wallflex fully covered biliary rmv stent was placed in the bile duct to relieve biliary obstruction due to intraductal papillary mucinous neoplasm (ipmn).The patient returned on march 13 due to obstruction.It was found that the stent had migrated proximally and there was a distal tissue ingrowth.Another stent was placed through the original occluded stent.On (b)(6) 2024, the patient was brought back to try to remove both stents.The second stent was removed without issue, however, the migrated stent retrieval wire snapped while trying to remove.Spyglass was passed through to visualize the proximal end of the stent and attempted to pull from that end, however, the retrieval was unsuccessful and the stent remains implanted.Another surgery was scheduled for intraductal papillary mucinous neoplasm (ipmn) to remove the stent.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on july 25, 2024.Block h6: imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Block h11: correction to the initial mdr in blocks d6b and h6 (impact codes and device codes).
Event or Problem Description
It was reported to boston scientific corporation that a wallflex fully covered biliary rmv stent was implanted in the distal bile duct for 2 months to relieve biliary obstruction on (b)(6) 2024.On (b)(6) 2024, a wallflex fully covered biliary rmv stent was placed in the bile duct to relieve biliary obstruction due to intraductal papillary mucinous neoplasm (ipmn).The patient returned on march 13 due to obstruction.It was found that the stent had migrated proximally and there was a distal tissue ingrowth.Another stent was placed through the original occluded stent.On (b)(6) 2024, the patient was brought back to try to remove both stents.The second stent was removed without issue, however, the migrated stent retrieval wire snaped while trying to remove.Spyglass was passed through to visualize the proximal end of the stent and attempted to pull from that end, however, the retrieval was unsuccessful, and the stent remains implanted.Another surgery was scheduled for intraductal papillary mucinous neoplasm (ipmn) to remove the stent.Additional information received on july 25, 2024.The stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The patient's anatomy was not dilated prior to stent placement.The patient's admission was related to the patient's underlying condition, intraductal papillary mucinous neoplasm (ipmn).Since the patient was scheduled for surgery, the stent was also planned to be removed at that time.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19705621
• Report Number: 3005099803-2024-03267
• Device Sequence Number: 12709083
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/20/2024

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: 09/19/2024
• Device Model Number: M00570360
• Device Catalogue Number: 56424
• Device Lot Number: 0030178307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Date Device Manufactured: 09/20/2022
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male