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

Model Number M00516710

Device Problem Material Integrity Problem (2978)

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

Event Date 03/29/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6), 2023, that a wallflex esophageal fully covered stent was implanted in the esophagus to treat an esophagotracheal fistula during an esophageal stent implantation procedure performed on an unknown date.The stent had been implanted for one month.On (b)(6) 2023, during the patient's review, it was noted that the implanted wallflex esophageal stent had laminating holes on the stent cover.The stent was removed from the patient with pincers.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note; a photo of the complaint device was provided by the complainant and showed the stent was outside the patient with holes on the stent cover.

Manufacturer Narrative

Block h6: imdrf device code a04 captures the reportable event of stent cover damage/defective.Impact code f23 is being used to capture the unexpected medical intervention to remove the stent.

• 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: 16801324
• MDR Text Key: 313899686
• Report Number: 3005099803-2023-02213
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Model Number: M00516710
• Device Catalogue Number: 1671
• Device Lot Number: 0029414697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG