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

Model Number	20233
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the biliary stricture vessel.A 10mmx40mm wallflex biliary transhepatic self-expanding stent was successfully placed.There were no complications or concerns post-procedure.During post-imaging follow-up, the stent had migrated to the bowel.The physician was not concerned as the stent would pass on its own through the patients bowel movement.
Additional Manufacturer Narrative
D6a - implant date: updated from blank to (b)(6) 2023.Device evaluated by mfr: the device was not returned to the complaint investigation site (cis) for analysis.In the picture attached can be observed the stent inside the patient anatomy; however, is not possible to determine if the stent migrated.No damages were noted in the picture attached.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the biliary stricture vessel.A 10mmx40mm wallflex biliary transhepatic self-expanding stent was successfully placed.There were no complications or concerns post-procedure.During post-imaging follow-up, the stent had migrated to the bowel.The physician was not concerned as the stent would pass on its own through the patient's bowel movement.It was further reported that the stent migrated a week after the implant date.The stricture was believed to have been resolved and no further treatment nor procedure was performed on the patient.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17491246
• Report Number: 2124215-2023-39015
• Device Sequence Number: 18099497
• Product Code: FGE
• UDI-Device Identifier: 08714729820505
• UDI-Public: 08714729820505
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/01/2023

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: 09/18/2024
• Device Model Number: 20233
• Device Catalogue Number: 20233
• Device Lot Number: 0030170933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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
• Patient Sex: Unknown