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

Model Number M00516900

Device Problems Obstruction of Flow (2423); Migration (4003)

Patient Problems Dysphagia/ Odynophagia (1815); Hematemesis (4478)

Event Date 01/06/2021

Event Type  Injury  

Event 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.

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).

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 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
• Type of Device: 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
• MDR Text Key: 299289519
• Report Number: 3005099803-2022-05046
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00516900
• Device Catalogue Number: 1690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death