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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Nausea (1970); Vomiting (2144)

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

Block a2: patient's weight: 143.3 lb.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation that a wallflex fully covered esophageal stent was implanted in the esophagus to treat a stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was not dilated prior to stent placement.During follow up, the stent was found to have migrated.On (b)(6) 2023, endoscopy was done, and stent fixation was performed using xtack.On (b)(6) 2023, stent removal was performed.The patient experienced minimal chest pain, abdominal pain, nausea and vomiting.Patient complications were resolved.

Manufacturer Narrative

Block a2: patient's weight: 143.3 lb.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h11: blocks b5, b7, d6a (implant date), and h6 (device and impact codes) have been corrected following a review which determined that the stent did not migrate, and an additional device was not required.

Event Description

It was reported to boston scientific corporation that a wallflex fully covered esophageal stent along with an xtack was implanted in the esophagus to treat a stricture during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to stent placement.During follow up, the stent was found to have migrated.On (b)(6) 2023, endoscopy was done, xtack was not visible and the intended therapeutic dwell time was reached.On (b)(6) 2023, stent removal was performed.The patient experienced minimal chest pain, abdominal pain, nausea and vomiting.Patient complications were resolved.

• 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: 18312437
• MDR Text Key: 330296860
• Report Number: 3005099803-2023-06645
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Race: White