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

Model Number M00516950

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 12/14/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

(b)(4).

• 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: 16090132
• MDR Text Key: 308494127
• Report Number: 3005099803-2022-07892
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: 08714729765295
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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