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

Model Number	M00516950
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the wallflex esophageal partially covered stent will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal partially covered stent was implanted to treat a benign stricture in the esophagus during a stent placement procedure performed on an unknown date.The patient's anatomy was not tortuous.On (b)(6) 2022, during a scheduled stent removal procedure, tissue ingrowth within the wallflex esophageal partially covered stent was noted.During the procedure, the green stent retention suture broke and the wallflex esophageal partially covered stent was unable to be removed.The wallflex esophageal partially covered stent remained implanted and the procedure was rescheduled.On (b)(6) 2022, gastroscopy procedure was performed and a boston scientific fully covered esophageal stent was implanted stent-in-stent to provide pressure necrosis to the tissue ingrowth.On (b)(6) 2022, both partially and fully covered esophageal stents were removed from the patient using a grasping forceps.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the wallflex esophageal partially covered stent was implanted to treat a benign esophageal stricture.Per the ifu, "the wallflex esophageal partially covered stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas".The stent is not indicated for the treatment of benign stricture.

• 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: 15288151
• Report Number: 3005099803-2022-04783
• Device Sequence Number: 11388941
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: 08714729765295
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 08/24/2022

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: 02/11/2024
• Device Model Number: M00516950
• Device Catalogue Number: 1695
• Device Lot Number: 0028851989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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