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

Model Number	M00570530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Nausea (1970); Vomiting (2144); Jaundice (2187)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx covered stent was implanted to treat a 3cm malignant stricture in the biliary tract during a stent implantation procedure performed on (b)(6) 2023.The patient anatomy was tight and was not dilated prior to stent placement.On (b)(6) 2023.Post stent placement, the patient presented with fever, nausea, vomiting, elevated bilirubin level and yellowing of the skin.It was noted that the stent migrated from its original location.The stent was removed from the patient with biopsy forceps.Another wallflex biliary stent was implanted, and the procedure was completed.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e230101 captures patient complication fever post stent placement.Imdrf patient code e1020 captures patient complication of nausea post stent placement.Imdrf patient code e1032 captures patient complication of vomiting post stent placement.Imdrf patient code e1709 captures patient complication of elevated bilirubin level and yellowing of the skin post stent placement.Impact code f23 captures the additional intervention of stent removal procedure.Impact code f2301 captures the biopsy forceps used to remove the migrated stent, and the additional stent implanted to complete the procedure.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e230101 captures patient complication fever post stent placement.Imdrf patient code e1020 captures patient complication of nausea post stent placement.Imdrf patient code e1032 captures patient complication of vomiting post stent placement.Imdrf patient code e1709 captures patient complication of elevated bilirubin level and yellowing of the skin post stent placement.Impact code f23 captures the additional intervention of stent removal procedure.Impact code f2301 captures the biopsy forceps used to remove the migrated stent, and the additional stent implanted to complete the procedure.Block h10: a wallflex biliary rx covered stent and delivery system were received for analysis.The stent was returned fully covered with a plastic sheath.The plastic sheath was removed, and no damages were noted to the stent.Visual examination of the returned delivery system found the clear outer sheath was kinked and accordioned.The inner sheath near the tip was noted to be kinked.No other issues were noted to the delivery system.The reported event of stent migration could not be confirmed as this occurred during the procedure, and no objective evidence or descriptive condition that would confirm the event.The damages noted to the returned device were most likely due to procedural actors encountered during the procedure.It may be the characteristics of the lesion, the manner the device was handled during procedure, the techniques used by the user, limited the performance of the device and contributed to the kinking of the delivery system.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, fever, nausea, vomiting and jaundice were documented within the ifu as a potential complication associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk.
Event or Problem Description
It was reported to boston scientific corporation on february 22, 2023, that a wallflex biliary rx covered stent was implanted to treat a 3cm malignant stricture in the biliary tract during a stent implantation procedure performed on (b)(6), 2023.The patient anatomy was tight and was not dilated prior to stent placement.On (b)(6), 2023.Post stent placement, the patient presented with fever, nausea, vomiting, elevated bilirubin level and yellowing of the skin.It was noted that the stent migrated from its original location.The stent was removed from the patient with biopsy forceps.Another wallflex biliary stent was implanted, and the procedure was completed.The patient condition following the procedure was reported to be stable.

• Brand Name: WALLFLEX 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; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16565248
• Report Number: 3005099803-2023-01305
• Device Sequence Number: 17513058
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

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: 04/04/2024
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0029171388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 58 KG