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

Model Number	M00516740
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an esophageal leak during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the white tip dislodged from the delivery system.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Additional Manufacturer Narrative
Blocks b1, b2 (outcomes attrib to adv event), b5, h1, and h6 (impact and device codes) have been updated with additional information received on july 16, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h11: correction to the initial mdr in block b5.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an esophageal leak during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the white tip dislodged from the delivery system.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.**additional information received on july 16, 2024** the patient's anatomy was not tortuous and was not dilated prior to stent placement.The dislodged tip was removed from the patient using an additional tool **update based on review** it was reported to boston scientific corporation that a wallflex esophageal stent was used to treat an esophageal leak.However, per the wallflex esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of esophageal leakage.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an esophageal leak during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the white tip dislodged from the delivery system.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Additional information received on july 16, 2024: the patient's anatomy was not tortuous and was not dilated prior to stent placement.The dislodged tip was removed from the patient using an additional tool update based on review: it was reported to boston scientific corporation that a wallflex esophageal stent was used to treat an esophageal leak.However, per the wallflex esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of esophageal leakage.Additional information received on august 12, 2024: the procedure was performed on (b)(6) 2024.
Additional Manufacturer Narrative
Blocks b3, b5, and h10 have been updated with additional information received on august 12, 2024.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h12: correction to the supplemental mdr in block h6 (evaluation result code and evaluation conclusion code).
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was used to treat an esophageal leak during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2024.During the procedure, the white tip dislodged from the delivery system.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Additional information received on july 16, 2024 the patient's anatomy was not tortuous and was not dilated prior to stent placement.The dislodged tip was removed from the patient using an additional tool update based on review it was reported to boston scientific corporation that a wallflex esophageal stent was used to treat an esophageal leak.However, per the wallflex esophageal fully covered stent system instructions for use (ifu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.The device is not indicated for the treatment of esophageal leakage.Additional information received on august 12, 2024, the procedure was performed on (b)(6) 2024.

• 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: 19746331
• Report Number: 3005099803-2024-03391
• Device Sequence Number: 20479492
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/28/2024

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: 07/09/2025
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0033014831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/12/2024; 10/01/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/12/2024; 09/04/2024; 10/28/2024
• Date Device Manufactured: 12/08/2023
• 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 Sex: Unknown