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

Model Number	M00516940
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was disposed and was not returned for evaluation; however, photos of the complaint device were provided.Media analysis confirmed the reported event of outer blue sheath accordioned.The inner sheath was found detached.No other visible issues were noted.It is likely that the patient's tight anatomy and the technique used by the physician limited the performance of the device and contributed to the reported event of outer sheath accordioned.However, there is not enough evidence to determine whether the reported event of stent failure to deploy and the inner sheath detached were due to the physician's technique or due to the procedural and anatomical conditions during the reported event, or whether it was related to a device malfunction during the procedure.The investigation findings did not lead to a clear conclusion about the cause of the reported event; without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of the event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6), 2022.The patient's anatomy was tortuous.During the procedure, when the wallflex esophageal stent was deployed, the delivery system got buckled/accordioned.The wallflex esophageal stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with another wallflex esophageal stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the media analysis on the photos of the complaint device provided by the complainant which revealed that the inner sheath was detached.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: 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: 15543535
• Report Number: 3005099803-2022-05821
• Device Sequence Number: 5593840
• Product Code: ESW
• UDI-Device Identifier: 08714729765288
• UDI-Public: 08714729765288
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2024
• Device Model Number: M00516940
• Device Catalogue Number: 1694
• Device Lot Number: 0029797427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown