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

Model Number	M00516950
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(4) 2022, that a walllfex partially covered esophageal stent was implanted to treat a malignant stricture post esophagectomy during a gastroscopy with stent placement procedure performed on (b)(4) 2022.During the procedure, several attempts were made to pass the stent delivery system through the pylorus.The wallflex esophageal stent was then successfully deployed.Under fluoroscopy.The tip of the delivery system appeared to be dislodged from the catheter and was placed in the duodenum.After removal of the delivery system, it was confirmed that the tip was detached and remained inside the patient.The physician decided to leave the tip inside the patient and allow the tip to pass naturally.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
(b)(4).

• 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: 16090132
• Report Number: 3005099803-2022-07892
• Device Sequence Number: 2009603
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: 08714729765295
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 01/03/2023

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: 02/10/2024
• Device Model Number: M00516950
• Device Catalogue Number: 1695
• Device Lot Number: 0028845106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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