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

Model Number M00516240

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was used during an esophageal stenting procedure performed on (b)(6) 2023.During the procedure, while advancing the delivery system, the white olive tip broke.The olive tip was removed along with the guidewire and there was no attempt to deploy the stent.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex esophageal fully covered stent and delivery system were received for analysis.Visual inspection found the outer blue sheath kinked.The tip was detached from the device and was not returned.Microscopic inspection on the distal section of the inner sheath found evidence of adhesive.No other problems with the stent and delivery system were noted.Product analysis confirmed the reported event of tip detachment of device or device component.It is most likely that procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied) could have resulted in the reported event and the observed event of sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was used during an esophageal stenting procedure performed on (b)(6)2023.During the procedure, while advancing the delivery system, the white olive tip broke.The olive tip was removed along with the guidewire and there was no attempt to deploy the stent.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.

• 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: 17764285
• MDR Text Key: 323600914
• Report Number: 3005099803-2023-04954
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516240
• Device Catalogue Number: 1624
• Device Lot Number: 0031100176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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