MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00516750
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat a gastrectomy leak of the gastroesophageal (ge) junction during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the tip of the device broke off when the device was inserted at the ge junction.The tip eventually fell into the abdominal cavity.The procedure was completed using a different esophageal stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat a gastrectomy leak of the gastroesophageal (ge) junction during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the tip of the device broke off when the device was inserted at the ge junction.The tip eventually fell into the abdominal cavity.The procedure was completed using a different esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.Block h6 has been updated following a review which determined that unretrieved device fragments code should be added.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.Block h11: a wallflex esophageal stent was received for analysis.Visual examination of the returned device found the stent fully covered and undeployed.Functional inspection was performed by actuating the delivery system (slide the handle back along the stainless-steel tube) and no problems were noted with the deployment of the stent.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of tip detachment of device or device component as the tip of the device was returned in good condition.There is no indication of what the customer reported because the stent was returned fully covered and undeployed with its tip in good condition.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the axios stent was used to treat a gastrectomy leak.The ifu states, "the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures.".
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat a gastrectomy leak of the gastroesophageal (ge) junction during an esophageal stenting procedure performed on (b)(6) 2024.During the procedure, the tip of the device broke off when the device was inserted at the ge junction.The tip eventually fell into the abdominal cavity.The procedure was completed using a different esophageal stent.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• 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: 19376796
• Report Number: 3005099803-2024-02402
• Device Sequence Number: 7466391
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K091510
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0032986659
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/06/2024; 08/16/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/25/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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
• Patient Sex: Unknown