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

Model Number M00516290

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h10: 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 fully covered esophageal stent rmv was to be implanted in the esophagus to treat esophageal stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the tip of the delivery system was detached and remained inside the patient.The detached tip was removed using forceps and the procedure was completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be okay.

Event Description

It was reported to boston scientific corporation that a wallflex fully covered esophageal stent rmv was to be implanted in the esophagus to treat esophageal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the tip of the delivery system was detached and remained inside the patient.The detached tip was removed using forceps and the procedure was completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be okay.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h10: imdrf device code a0501 captures the reportable event of tip detachment of device or device component block h11: block b5 has been corrected following a review which determined an esophageal stent procedure is not related to ercp.

• 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: 18296734
• MDR Text Key: 330085554
• Report Number: 3005099803-2023-06348
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516290
• Device Catalogue Number: 56454
• Device Lot Number: 0031709161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2023
• 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