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

Model Number	M00516930
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	02/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device 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 march 26, 2021 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal perforation during a stent placement procedure performed on (b)(6) 2021.The patient had a 2 mm puncture from external erosion of a granuloma into the esophagus.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was successfully deployed in the correct location.However, it was noted that the stent did not seal the perforation and fluid was going through the stent and out the esophageal perforation.The physician attempted to reposition the stent but there still appeared to be a leak.The stent was removed from the patient with forceps, and another wallflex esophageal stent was implanted to complete the procedure.Reportedly, the physician noticed a small tear in the stent cover.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex esophageal partially covered stent was used to seal an esophageal perforation.Per wallflex esophageal partially covered stent system directions for use (dfu), the stent is indicated 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 treat esophageal perforation.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11686992
• Report Number: 3005099803-2021-01756
• Device Sequence Number: 19615115
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• UDI-Public: 08714729765271
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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 Model Number: M00516930
• Device Catalogue Number: 1693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention