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

Model Number M00516700

Device Problems Positioning Failure (1158); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat a malignant esophageal stenosis during an esophageal stent placement procedure performed on (b)(6) 2022.During the procedure, the wallflex esophageal stent was unable to be deployed.The wallflex esophageal stent was removed from the patient fully covered by the outer sheath.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the tip of the wallflex esophageal delivery system was bent.

Manufacturer Narrative

(b)(4).A wallflex esophageal fully covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection was performed and found the outer blue sheath was kinked and accordioned.The tip of the delivery system was bent.Functional evaluation was performed and revealed the stent was able to be deployed.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy could not be confirmed; the stent was able to be deployed during functional inspection.Based on the available information, the investigation concluded that the observed failures were most likely due to procedural factors encountered during the procedure.It may be that handling and manipulation of the device during procedure, limited the performance of the device.Therefore, contributing to the outer sheath becoming kinked and accordion and bent tip, which resulted in stent partial deployment.Forcing the device against significant resistance during use could result in device damage, or loss of device functionality.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 15188433
• MDR Text Key: 305275573
• Report Number: 3005099803-2022-04360
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0026389028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG