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

Model Number	M00516750
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001); Ulcer (2274)
Date of Event	06/05/2023
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 a 4-5 cm malignant esophageal stricture during a procedure performed on an unknown date.The patient's anatomy was not tight and was not dilated prior to stent placement.On (b)(6) 2023, the patient presented with pain.Imaging test showed the stent migrated into the stomach and formation of an ulcer was noted at the distal portion of the stent that turned into a perforation.An esophagogastroduodenoscopy (egd) procedure was performed, and the stent was removed from the patient with rescue combo forceps.The stricture was reported to be resolved at the time of migration.The physician attempted to close the perforation with mantis clips, but the tissue was too friable, and the clips would not grasp on to the tissue.The procedure was not completed, and the perforation was not closed.Closure of the perforation was scheduled for the next 7-10 days.
Additional Manufacturer Narrative
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 stent migration.Imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf patient code e2330 captures the reportable patient symptom of pain.Imdrf patient code e2339 captures the reportable patient complication of ulcer in the stomach.Impact code f2202 is being used to captures the egd procedure performed to remove the migrated stent.Impact code f2301 is being used to capture the used of clips to close the perforation.Impact code f08 is being used to capture patient admitted beyond the standard of care.
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 a 4-5 cm malignant esophageal stricture during a procedure performed on an unknown date.The patient's anatomy was not tight and was not dilated prior to stent placement.On (b)(6) 2023, the patient presented with pain.Imaging test showed the stent migrated into the stomach and formation of an ulcer was noted at the distal portion of the stent that turned into a perforation.An esophagogastroduodenoscopy (egd) procedure was performed, and the stent was removed from the patient with rescue combo forceps.The stricture was reported to be resolved at the time of migration.The physician attempted to close the perforation with mantis clips, but the tissue was too friable, and the clips would not grasp on to the tissue.The procedure was not completed, and the perforation was not closed.Closure of the perforation was scheduled for the next 7-10 days.Additional information received on june 30, 2023.It was reported that on (b)(6) 2023, another esophageal stent was implanted on the patient, and it was clipped in place to potentially prevent migration.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on june 30, 2023.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 (b)(6) captures the reportable event of stent migration.Imdrf patient code (b)(6) captures the reportable patient complication of perforation.Imdrf patient code (b)(6) captures the reportable patient symptom of pain.Imdrf patient code (b)(6) captures the reportable patient complication of ulcer in the stomach.Impact code (b)(6) is being used to captures the egd procedure performed to remove the migrated stent.Impact code (b)(6) is being used to capture the used of clips to close the perforation.Impact code (b)(6) is being used to capture patient admitted beyond the standard of care.

• 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: 17189939
• Report Number: 3005099803-2023-03402
• Device Sequence Number: 14863519
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/20/2023

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 Model Number: M00516750
• Device Catalogue Number: 1675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 07/20/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Race: White