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

Model Number	M00570540
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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 to be implanted in the bile duct to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, after the stent was implanted, the stent cover ruptured, and several holes were noted under the scope.The stent was removed from the patient and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary stent was to be implanted to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) procedure.However, the wallflex biliary rx fully covered stent system instructions for use (ifu) states, "the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstructions prior to surgery." the wallflex biliary stent is not indicated to treat benign strictures.Photos of the complaint device were provided by the complainant showing the stent was deployed inside the patient with holes on the stent cover.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.
Additional Manufacturer Narrative
Blocks a1 and e1 (initial reporter address 1, address 2, city, and zip/post code) have been updated with additional information received on may 15, 2023.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.
Event or Problem Description
It was reported to boston scientific corporation on april 24, 2023 that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, after the stent was implanted, the stent cover ruptured, and several holes were noted under the scope.The stent was removed from the patient and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary stent was to be implanted to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) procedure.However, the wallflex biliary rx fully covered stent system instructions for use (ifu) states, "the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstructions prior to surgery." the wallflex biliary stent is not indicated to treat benign strictures.Photos of the complaint device were provided by the complainant showing the stent was deployed inside the patient with holes on the stent cover.
Additional Manufacturer Narrative
Blocks b5, d2b, d4 (model number, lot number, catalog number, expiration date, unique identifier #), g4, and h4 have been updated with additional information received on june 19, 2023.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged.Block h10: the device was not returned; however, photos of the device were provided.Media inspection did not confirm the reported event of stent cover damaged/defective as the stent inside the patient's anatomy does not correspond to a wallflex biliary stent.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the wallflex biliary stent was to be implanted to treat a 2-3 cm benign stricture for biliary drainage with stone extraction.The ifu states, "the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstructions prior to surgery." the reported event of stent cover damaged/defective was not confirmed as the photos provided does not correspond to a wallflex biliary stent during media inspection.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation on april 24, 2023 that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not dilated prior to stent placement.During the procedure, after the stent was implanted, the stent cover ruptured, and several holes were noted under the scope.The stent was removed from the patient and the procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary stent was to be implanted to treat a 2-3 cm benign stricture for biliary drainage with stone extraction during an endoscopic retrograde cholangiopancreatography (ercp) procedure.However, the wallflex biliary rx fully covered stent system instructions for use (ifu) states, "the stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstructions prior to surgery." the wallflex biliary stent is not indicated to treat benign strictures.Photos of the complaint device were provided by the complainant showing the stent was deployed inside the patient with holes on the stent cover.The stent was removed using snare.

• 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: 16936072
• Report Number: 3005099803-2023-02593
• Device Sequence Number: 5830389
• Product Code: PNB
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/30/2023
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0028473189
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 06/19/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 05/17/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 62 KG