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

Model Number	M00516710
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 16801324
• Report Number: 3005099803-2023-02213
• Device Sequence Number: 11522516
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: 08714729778042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG