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

Model Number M00516250

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

Block e1: dr.Massimo di simone reported the event to bsc.The physician who performed the procedure was dr giulio cariani.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2024-01890 and 3005099803-2024-01720 for the associated device information.It was reported to boston scientific corporation that two wallflex esophageal fully covered stents rmv were to be implanted in the esophagus to treat a malignant stricture during an esophageal metal stent positioning procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the white olive tip of the wallflex esophageal (the subject of manufacturer report # 3005099803-2024-01890) device was detached when the device was introduced into the guidewire outside of the patient.A second wallflex esophageal stent was opened (the subject of this report), and the same problem occurred.The procedure was completed with another of the same device.There were no patient complications reported as a result of the 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: 19187937
• MDR Text Key: 341421997
• Report Number: 3005099803-2024-01720
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/25/2024

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: M00516250
• Device Catalogue Number: 1625
• Device Lot Number: 0032914771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• 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