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

Model Number M00516210

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/13/2021

Event Type  Injury  

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).

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex fully covered esophageal stent was implanted in the esophagus to treat fistula during a stent placement procedure performed on (b)(6) 2021.On (b)(6) 2021, post stent placement, an esophagogastroduodenoscopy (egd) procedure was performed and it was found that the walllfex esophageal stent had migrated.The wallflex esophageal stent was removed from the patient with forceps.Another esophageal stent was implanted and the procedure was completed.On an unknown date, the patient passed away.

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 stent migration.

Event Description

It was reported to boston scientific corporation on august 22, 2022 that a wallflex fully covered esophageal stent was implanted in the esophagus to treat fistula during a stent placement procedure performed on (b)(6) 2021.On (b)(6) 2021, post stent placement, an esophagogastroduodenoscopy (egd) procedure was performed and it was found that the walllfex esophageal stent had migrated.The wallflex esophageal stent was removed from the patient with forceps.Another esophageal stent was implanted and the procedure was completed.On an unknown date, the patient passed away.**additional information received on september 08, 2022**.On (b)(6) 2021, post stent placement, the walllfex esophageal stent had migrated proximally and was removed from the patient.In (b)(6) 2022, the patient passed away due to pleural effusion.In the physician's assessment, the patient's death is unrelated to the wallflex esophageal stent.

• 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: 15383538
• MDR Text Key: 299548151
• Report Number: 3005099803-2022-05123
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: SIMILAR
• 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: M00516210
• Device Catalogue Number: 1621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/08/2022
• 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