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

Model Number M00516900

Device Problem Material Integrity Problem (2978)

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

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation on january 03, 2023, that a wallflex esophageal stent was to be implanted to treat a stricture during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During the procedure, the wallflex esophageal stent was fully deployed; however, it was noted that the stent cover was torn.The wallfex esophageal stent was removed from the patient with rat tooth forceps.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• 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: 16233243
• MDR Text Key: 308002796
• Report Number: 3005099803-2023-00189
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: M00516900
• Device Catalogue Number: 1690
• Device Lot Number: 0027619683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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