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

Model Number	M00570380
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted to treat cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2024.During the procedure, the stent did not foreshorten as expected and was found to be too long.The stent was removed from the patient, and the procedure was completed using another of the same device.No patient complications were reported as a result of this event.Note: no further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Blocks b5 and h6 (impact code) have been updated with the additional information received on october 30, 2024.Block h6: imdrf device code a0203 captures the reportable event of stent size incorrect.Note: this complaint is no longer considered mdr reportable.The stent being too long for the patient's anatomy is not classified as a device malfunction.Furthermore, no patient complications were reported in relation to this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted to treat cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2024.During the procedure, the stent did not foreshorten as expected and was found to be too long.The stent was removed from the patient, and the procedure was completed using another of the same device.No patient complications were reported as a result of this event.***additional information received on october 30, 2024*** it was reported that the wallflex biliary stent was intended for implantation in the bile duct.However, the stent was found to be too long for the patient's anatomy and was subsequently removed using a rat tooth retrieval device.

• 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: 20559693
• Report Number: 3005099803-2024-05411
• Device Sequence Number: 8866154
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 06/26/2026
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Device Lot Number: 0034316194
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Date Device Manufactured: 06/26/2024
• 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 Sex: Unknown