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

Model Number	M00516700
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was contaminated 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 that on february 11, 2021 a wallflex esophageal fully covered stent was implanted to treat a stenosis in the middle esophagus during a stent placement procedure performed on (b)(6) 2021.On (b)(^) 2021, the patient presented with dysphagia and emergency imaging was performed.It was noted that the stent migrated to the gastric chamber.The patient's anatomy was dilated to 15cm and the stent was removed together with the three clips which that were intended to keep the stent in place.A new stent was not placed during the procedure due to the dilation size of the anatomy.Radiotherapy and quantitative magnetization (qmt) were started to treat the patient with some improvements, and another stent will be placed.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 11426752
• Report Number: 3005099803-2021-00942
• Device Sequence Number: 4076238
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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 Expiration Date: 04/21/2022
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0026221911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/07/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR