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

Model Number	M00516730
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.D4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.H6: imdrf device code a010402 captures the reportable event of a stent's migration.Imdrf patient code e1009 captures the patient's dysphagia.Imdrf impact code f23 captures the unexpected medical intervention to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant obstructive esophageal tumor during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2022.On (b)(6) 2022, the patient was scheduled for cryotherapy for an esophageal tumor, and it was noticed during the procedure that the stent had completely migrated to the distal part of the anatomy.On the same day, the stent was adjusted and re-sutured in place using the apollo overstitch.On (b)(6) 2022, the stent was removed from the patient using graspers.The patient was reported to have experienced dysphagia.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a010402 captures the reportable event of a stent's migration.Imdrf patient code e1009 captures the patient's dysphagia.Imdrf impact code f23 captures the unexpected medical intervention to remove the stent.Block h11: blocks b5 and h6 (device codes) were corrected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant obstructive esophageal tumor during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2022.On (b)(6) 2022, the patient was scheduled for cryotherapy for an esophageal tumor, and it was noticed during the procedure that the stent had completely migrated to the distal part of the anatomy.On the same day, the stent was adjusted and re-sutured in place using the apollo overstitch.On (b)(6) 2022, the stent was removed from the patient using graspers.The patient was reported to have experienced dysphagia.Note: it was reported that the stent was re-sutured in place using the apollo overstitch.Although suturing the stent is a documented practice in clinical literature, it is not in the labeling.

• 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: 18810778
• Report Number: 3005099803-2024-00728
• Device Sequence Number: 3325469
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Report Date (Section B): 06/04/2024

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 Model Number: M00516730
• Device Catalogue Number: 1673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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