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

Model Number	M00516910
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was used to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The handle felt flimsy and the white olive tip was detached from the delivery system.The stent was fully covered by the outer sheath when it was removed from the patient.There was no attempt to remove the tip from the patient and the physician decided to let the tip pass out naturally.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was used to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The handle felt flimsy and the white olive tip was detached from the delivery system.The stent was fully covered by the outer sheath when it was removed from the patient.There was no attempt to remove the tip from the patient and the physician decided to let the tip pass out naturally.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: a wallflex esophageal partially covered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the tip detached and was not returned.The outer blue sheath and the outer clear sheath were kinked.During functional inspection, the stent was deployed without any problems by actuating the delivery system.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of tip detachment of device or device component; however, the reported event of stent failure to deploy was not confirmed as the stent was able to be deployed during functional inspection.It is most likely that procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) resulted in the reported event of tip detached and the observed events of outer blue sheath and outer clear sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: 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: 18393344
• Report Number: 3005099803-2023-06798
• Device Sequence Number: 12953545
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2024
• Device Model Number: M00516910
• Device Catalogue Number: 1691
• Device Lot Number: 0030736852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown