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 04/05/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was to be implanted in the esophagus to treat a tumor stenosis during a gastroscopy procedure performed on (b)(6) 2024.During the procedure, the tip detached and was removed from the patient using a net.The procedure was not completed.On (b)(6) 2024, another wallflex esophageal stent was successfully implanted.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0501 captures the reportable event of tip detached.H11: block h6 (impact codes) has been corrected.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was to be implanted in the esophagus to treat a tumor stenosis during a gastroscopy procedure performed on (b)(6) 2024.During the procedure, the tip detached and was removed from the patient using a net.The procedure was not completed.On (b)(6) 2024, another wallflex esophageal stent was successfully implanted.There were no patient complications as a result of this event.It was further reported that the stent was placed in a malignant tumor.

• 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: 19213442
• MDR Text Key: 341393325
• Report Number: 3005099803-2024-01909
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• 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
• Is the Reporter a Health Professional?: Yes
• 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