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

Model Number M00516700

Device Problem Migration (4003)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 01/20/2021

Event Type  Injury  

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 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
• Type of Device: 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: 11426752
• MDR Text Key: 238614226
• Report Number: 3005099803-2021-00942
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR