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

Model Number	M00570520
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Perforation (2001); Sepsis (2067)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.H6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code (b)(6) captures the reportable event of perforation.Imdrf patient code (b)(6) captures the reportable event of abdominal pain.Imdrf impact code f19 captures the reportable event of surgical intervention performed.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f0801 captures the reportable event of admission to the intensive care unit.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered stent was to be implanted in the common bile duct post papillectomy during a procedure performed on an unknown date.On (b)(3) 2023, the patient returned to the hospital after experiencing severe abdominal pain.It was later noted during a computed tomography (ct) scan that the stent migrated into the duodenum, which resulted in perforation.Surgery was performed to remove the stent and to address the perforation.The patient was admitted to the intensive care unit (icu) and the patient's current condition was reported to be poor.
Event or Problem Description
It was reported to boston scientific (bsc) that the referenced wallflex biliary rx fully covered stent was implanted in the common bile duct following an endoscopic papillectomy procedure, which is outside the indications for use per the device's instructions for use (ifu), and a plastic stent was placed through the referenced wallflex biliary rx fully covered stent.After the implant procedure, during a follow-up on (b)(6) 2023, it was reported that the patient had improved, and the stent was confirmed to be correctly in place.On (b)(6) 2023, the patient returned to the hospital after experiencing severe abdominal pain.A computed tomography (ct) scan noted that the stent had migrated into the duodenum, which resulted in perforation.Surgery was performed to remove the stent and to address the perforation.The patient was admitted to the intensive care unit (icu) and the patient's current condition was reported to be poor.Additional information received on january 26, 2024 and february 6, 2024.On (b)(6) 2024, it was reported that the patient subsequently passed away due to sepsis in the icu.On february 6, 2024, it was reported that in the physician's assessment, the stent did not directly cause the patient's death.However, stent migration, along with the post interventional pancreatitis, sepsis, multiple surgeries and other interventions contributed to the patient's death.
Additional Manufacturer Narrative
Blocks b5 and h6 (patient codes and impact codes) have been updated with the additional information received on january 26, 2024, and february 6, 2024.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2114 captures the reportable event of perforation.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf impact code f19 captures the reportable event of surgical intervention performed.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f0801 captures the reportable event of admission to the intensive care unit.Block h11: blocks b5 and g1 (mfr site address 1, mfr site city and mfr site country) have been corrected.

• 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: 18355324
• Report Number: 3005099803-2023-06627
• Device Sequence Number: 6885838
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140630
• 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
• Report Date (Section B): 02/20/2024

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 Model Number: M00570520
• Device Catalogue Number: 7052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown