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

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The wallflex esophageal stent has not been received for analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Stent migration is a known potential adverse effect associated with esophageal stent placement and is noted within the instructions for use (ifu) / product label.Therefore, the investigation concludes that the most probable cause of the event is a known inherent risk of the device.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal stent was implanted in the mid esophagus to treat a tracheoesophageal fistula during a procedure performed on an unknown date.On (b)(6) 2022, post stent placement, the wallflex esophageal stent migrated.It was noted that it was not a complete migration.The stent was removed from the patient and an agile esophageal stent was implanted and the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks b5 has been updated with additional information received on june 10, 2022.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a010402 captures the reportable event of stent migration.Impact code f23 captures the additional intervention of stent removal and replacement of the migrated stent.Block h10: the wallflex esophageal stent has not been received for analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Stent migration is a known potential adverse effect associated with esophageal stent placement and is noted within the instructions for use (ifu) / product label.Therefore, the investigation concludes that the most probable cause of the event is a known inherent risk of the device.

Event Description

It was reported to boston scientific corporation on may 18, 2022 that a wallflex esophageal stent was implanted in the mid esophagus to treat a tracheoesophageal fistula during a procedure performed on an unknown date.On may 18, 2022, post stent placement, the wallflex esophageal stent migrated.It was noted that it was not a complete migration.The stent was removed from the patient and an agile esophageal stent was implanted and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on june 10, 2022.The complainant reported that the stent migrated about an inch in the center of the esophagus.

• 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: 14655316
• MDR Text Key: 293726686
• Report Number: 3005099803-2022-03135
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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?: Yes
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention