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

Model Number	M00516900
Medical Device Problem Codes	Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Hematemesis (4478)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal stent was implanted in the esophagus to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2020.On (b)(6) 2021, post stent placement, the patient presented with dysphagia and hematemesis.An esophagogastroduodenoscopy (egd) procedure was performed and it was found that the wallflex esophageal stent had occlusion, proximal overgrowth and had migrated distally.The wallflex esophageal stent remained implanted and another partially covered esophageal stent was placed more proximal to bridge the affected area and the procedure was completed.On an unknown date, the patient passed away and the wallflex esophageal stent was buried with patient.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).
Additional Manufacturer Narrative
Blocks b2 (outcomes attrib to adv event), b5, b7, h1, and h6 (impact codes) have been updated with the additional information received on september 08, 2022.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 wallflex esophageal stent migration.Imdrf device code a1409 captures the reportable event of wallflex esophageal stent obstruction within device.Impact code f23 is being used to capture the additional intervention to place another esophageal stent.
Event or Problem Description
It was reported to boston scientific corporation on august 15, 2022 that a wallflex esophageal stent was implanted in the esophagus to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2020.On january 06, 2021, post stent placement, the patient presented with dysphagia and hematemesis.An esophagogastroduodenoscopy (egd) procedure was performed and it was found that the wallflex esophageal stent had occlusion, proximal overgrowth and had migrated distally.The wallflex esophageal stent remained implanted and another partially covered esophageal stent was placed more proximal to bridge the affected area and the procedure was completed.On an unknown date, the patient passed away and the wallflex esophageal stent was buried with patient.It was reported that a tissue was growing inside the proximal uncovered stent margin.An 18x103 mm wallflex esophageal stent was implanted to complete the procedure.In may 2021, the patient passed away due to aspiration pneumonia.In the physician's assessment, the dysphagia and hematemesis were unrelated to the patient's death.

• 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: 15362124
• Report Number: 3005099803-2022-05046
• Device Sequence Number: 17654849
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: M00516900
• Device Catalogue Number: 1690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 09/30/2022
• 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; Death
• Patient Sex: Unknown