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

Model Number	M00516730
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the mid esophagus to treat a benign esophageal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was able to be deployed.However, under fluoroscopic view, it was noted that the distal end of the stent did not fully expand.During removal of the stent delivery system, the tip of the delivery system got caught on the distal flanges of the stent, which caused the stent to be removed unintentionally.The stent was eventually removed using retrieval forceps, and the procedure was completed using another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: according to the complainant, there was no malignancy at the intended anatomy.However, per the wallflex esophageal fully covered stent system instructions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The stent is not indicated to be placed in benign strictures.

• 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: 20279766
• Report Number: 3005099803-2024-04542
• Device Sequence Number: 12759274
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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: 12/10/2025
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0034005821
• 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: 08/27/2024
• Initial Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 05/10/2024
• 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