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

Model Number	M00516730
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal fully covered stent was to be implanted in the mid-esophagus to treat a benign stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the physician misdeployed the wallflex esophageal stent; consequently, the wallflex esophageal stent was placed above the stricture.The wallflex esophageal stent was removed from the patient with rat-tooth grasping forceps and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex esophageal fully covered stent was to be implanted to treat a benign esophageal stricture.Per the instructions for use (ifu), "the wallflex esophageal fully covered stent system 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 for the treatment of benign stricture.
Additional Manufacturer Narrative
(b)(6).(b)(4).

• 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: 15512011
• Report Number: 3005099803-2022-05631
• Device Sequence Number: 5824786
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: 05/31/2023
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0028469181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/30/2022
• 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 Sex: Unknown