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

Model Number M00516260

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A wallflex esophageal fully covered rmv stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received completely deployed.The green retention suture was found broken and holes were noted on the stent cover.The outer sheath was kinked approximately between 13 and 51 cm from the tip of the delivery system.The outer diameter (od) of the stent was measured and was found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was not confirmed; the stent was received fully deployed.Taking all available information into consideration, the investigation concluded that the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, the interaction of the device with the scope, and/or the anatomy of the patient, limited the performance of the device and contributed to the kinks on the outer sheath and holes on the stent cover.Additionally, the broken green retention suture may have been a result when the physician attempted to disengage the end of the stent during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / 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 esophagus during an esophageal stent deployment procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent did not fully deploy.The device was removed with the stent partially deployed on the delivery system and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the green suture was broken and the stent cover was damaged (holes).

• 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: 10453531
• MDR Text Key: 204375136
• Report Number: 3005099803-2020-03537
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2021
• Device Model Number: M00516260
• Device Catalogue Number: 1626
• Device Lot Number: 0024604134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• 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