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

Model Number M00516750

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  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat a stricture during an esophageal stent placement procedure performed on an unknown date.During the procedure, the tip of the stent was detached outside the patient's body.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted in the esophagus to treat a stricture during an esophageal stent placement procedure performed on an unknown date.The patient's anatomy was dilated prior to stent placement.During the procedure, the tip of the stent was detached outside the patient's body.A different device was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h11: a wallflex esophageal stent was received for analysis.Visual examination of the returned device found the stent fully covered and undeployed.Additionally, the tip was not returned as it was detached, and the outer sheath was kinked.Media analysis of the photo provided by the complainant was performed, and it was observed that the tip was detached.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of tip detached.Taking all available information into consideration, the investigation concluded that the reported events of tip detached and sheath kinked were likely due to factors encountered during the procedure such as lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the reported events.Therefore, the most probable cause of the reported event is adverse event related to 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: 19215782
• MDR Text Key: 341675607
• Report Number: 3005099803-2024-01933
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• 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: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0032998177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• 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