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

Model Number M00516320

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Block e1: (b)(6) hospital.Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: according to the complainant, the wallflex esophageal stent was disposed and will not be available for return; therefore, a technical product analysis could not be performed.However, photos of the complaint device were provided, and it was observed that the white tip on the end of the stent was missing.Media analysis confirmed the reported event of tip detachment of device or device component.Based on the available information, there is not enough evidence to determine whether the cause of the reported event was due to the physician's technique during the procedure, or due to the anatomical conditions, or was related to a device malfunction.The investigation concluded that, without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable cause of the event.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was to be implanted in the esophagogastric junction to treat a tumor during a stent placement procedure performed on (b)(6) 2023.During the procedure, the guidewire was loaded with the stent and the device was advanced; however, it was determined that the stent was not "appropriate" and was removed.Subsequently, upon removal of the stent, it was noted that the white olive tip was detached.They went back in with the scope but were unable to find the detached tip.The patient's bed and clothing were also checked but the tip was still unable to be found.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: photos of the complaint devices were provided showing that the white olive tip was detached.

Manufacturer Narrative

Blocks b5, g2, and h6 (impact codes and device codes) have been updated with additional information received on december 08, 2023.Block e1: the name of the healthcare facility is (b)(6) hospital.The complete address of the healthcare facility is (b)(6) united kingdom.Block g2: report source: mhra case reference # (b)(4).Block h6: imdrf device code a0501 captures the reportable event of tip detached.Block h10: according to the complainant, the wallflex esophageal stent was disposed and will not be available for return; therefore, a technical product analysis could not be performed.However, photos of the complaint device were provided, and it was observed that the white tip on the end of the stent was missing.Media analysis confirmed the reported event of tip detachment of device or device component.Based on the available information, there is not enough evidence to determine whether the cause of the reported event was due to the physician's technique during the procedure, or due to the anatomical conditions, or was related to a device malfunction.The investigation concluded that, without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable cause of the event.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered rmv stent was to be implanted in the esophagogastric junction to treat a tumor during a stent placement procedure performed on (b)(6) 2023.During the procedure, the guidewire was loaded with the stent and the device was advanced; however, it was determined that the stent was not "appropriate" and was removed.Subsequently, upon removal of the stent, it was noted that the white olive tip was detached.They went back in with the scope but were unable to find the detached tip.The patient's bed and clothing were also checked but the tip was still unable to be found.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: photos of the complaint devices were provided showing that the white olive tip was detached.Additional information received on december 08, 2023.Boston scientific was made aware of additional information related to this event through an adverse event incident report from the nhs national services scotland via email, iric investigation ref: (b)(4), iric occurrence ref: (b)(4) and mhra case ref: (b)(4).During the procedure, the stent could not be deployed due to its poor position.After the procedure, the patient felt well and was sent for an x-ray.

• 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: 18040206
• MDR Text Key: 326979457
• Report Number: 3005099803-2023-05726
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00516320
• Device Catalogue Number: 1632
• Device Lot Number: 0031579329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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