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

Model Number M00516940

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that a wallflex partially covered esophageal stent was implanted in the esophagus to treat a malignant stricture post radiotherapy treatment during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully placed; however, when the delivery system was removed, the inner sheath was detached and was lodged in the stent.The detached inner sheath was attempted to be removed with rat-tooth forceps and pediatric forceps but both attempts were unsuccessful.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks b5 and h6 (patient codes) have been updated with additional information received on (b)(6) 2023.Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex partially covered esophageal stent was implanted in the esophagus to treat a malignant stricture post radiotherapy treatment during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully placed; however, when the delivery system was removed, the inner sheath was detached and was lodged in the stent.The detached inner sheath was attempted to be removed with rat-tooth forceps and pediatric forceps but both attempts were unsuccessful.The stent remained implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on (b)(6) 2023 a day post stent placement, x-ray imaging was performed, and it was noted that the stent's full radial expansion resulted in the detached inner sheath falling into the patient's stomach.

Manufacturer Narrative

Block b5 has been updated with additional information received on june 23, 2023.Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.

Event Description

It was reported to boston scientific corporation on may 24, 2023 that a wallflex partially covered esophageal stent was implanted in the esophagus to treat a malignant stricture post radiotherapy treatment during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully placed; however, when the delivery system was removed, the inner sheath was detached and was lodged in the stent.The detached inner sheath was attempted to be removed with rat-tooth forceps and pediatric forceps but both attempts were unsuccessful.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.A day post stent placement, x-ray imaging was performed and it was noted that the stent's full radial expansion resulted in the detached inner sheath falling into the patient's stomach.The detached inner sheath that fell into the stomach passed out naturally from the patient.The patient was good following the 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: 17097626
• MDR Text Key: 316887359
• Report Number: 3005099803-2023-03001
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K073266
• 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,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516940
• Device Catalogue Number: 1694
• Device Lot Number: 0030617785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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