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

Model Number M00516730

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/07/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of wallflex esophageal stent partially deployed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex esophageal fully covered stent was to be implanted to treat a malignant stricture in the esophagus due to esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be unsheathed from the delivery system.The wallflex esophageal stent was removed from the patient partially deployed on the delivery system.Another wallflex esophageal stent was used to complete the procedure.There were no reported patient complications as a result of this event.Note: no further information has been obtained despite good faith efforts.

• 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: 16835602
• MDR Text Key: 314272963
• Report Number: 3005099803-2023-02238
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2023

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 Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0030925405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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