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

Model Number M00516260

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/01/2024

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent rmv was to be implanted during a procedure on an unknown date.During the procedure, when the stent was placed, the white tip at the distal end of the delivery system came off on its own.This was discovered during the patient's treatment.The tip then had to be removed using foreign body forceps.There were no patient complications reported as a result of the event.

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Initial reporter's facility information: (b)(6).Imdrf device code a0501 captures the reportable event of tip detachment.

Manufacturer Narrative

Blocks b3, b5, e1 (initial reporter title, initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter country, initial reporter zip/post code and initial reporter phone), e2 and e3, g2, h6 (device codes) and h11 have been updated with the additional information received on may 7, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent rmv was to be implanted during a procedure on an unknown date.During the procedure, when the stent was placed, the white tip at the distal end of the delivery system came off on its own.This was discovered during the patient's treatment.The tip then had to be removed using foreign body forceps.There were no patient complications reported as a result of the event.***additional information received on may 7, 2024***.It was reported that the wallflex esophageal fully covered stent rmv was to be implanted in the esophagus to treat a stricture during an oesophagogastroduodenoscopy (ogd) procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the attempted deployment, the white tip at the distal end of the delivery system came off on its own.The stent was fully covered by the outer sheath when it was removed from the patient and another wallflex esophageal stent was used to complete the procedure.

• 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: 19216993
• MDR Text Key: 341432999
• Report Number: 3005099803-2024-01892
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

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 Model Number: M00516260
• Device Catalogue Number: 1626
• Device Lot Number: 0032994874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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