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

Model Number	20234
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a covered stent, labeled as an uncovered stent, was implanted and partially migrated.A wallflex transhepatic uc 10mmx100mm self-expanding stent was used in a biliary stent procedure, for duodenal stenosis.The stent was implanted and the procedure ended successfully.Three days later, the patient returned to the hospital with pain/complications.An upper gastrointestinal endoscopy was performed.The stenosis and the biliary stent were easily passed with a therapeutic gastroscope.The biliary stent was seen, partially migrated, but still largely within the biliary tree.The physician elected not to place a duodenal stent.The patient would be upgraded to a soft diet and aim for discharge.Additionally, it was noted that when the uncovered stent was viewed endoscopically, it appeared to be a covered stent.Further information was reported indicating that the patient needed a second intervention.At that time no retrieval hook was found.No additional patient complications were reported.
Additional Manufacturer Narrative
The wallflex transhepatic stent was not returned, as it remains implanted.However images provided by the field were reviewed.Imaging of the stent placement procedure revealed that a 10 cm stent was placed.A long segment of the stent was deployed in the duodenum.This length of the stent that was deployed in the duodenum, corresponds to the length of the stent visualized in the endoscopic image.Fluoroscopic images of the percutaneous stent placement procedure showed that there is no retrieval loop on the implanted stent.Additionally, it was confirmed that this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.However, without proper evaluation of the device, the clinical observations cannot be confirmed.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14961440
• Report Number: 2134265-2022-07162
• Device Sequence Number: 15177412
• Product Code: FGE
• UDI-Device Identifier: 08714729799351
• UDI-Public: 08714729799351
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2022

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: 01/10/2024
• Device Model Number: 20234
• Device Catalogue Number: 20234
• Device Lot Number: 0028651828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male