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

Model Number	M00516700
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal stent was to be implanted in the esophagus to treat malignant stricture due to esophageal cancer during a stent placement procedure performed on (b)(6) 2022.During the procedure, after stent deployment, it was observed that the stent was displaced.The stent was removed and another wallflex esophageal stent was implanted to complete the procedure.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: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on may 18, 2022 that a wallflex esophageal stent was to be implanted in the esophagus to treat malignant stricture due to esophageal cancer during a stent placement procedure performed on (b)(6) 2022.Post stent placement, it was observed that the stent was displaced.The stent was removed and another wallflex esophageal stent was implanted to complete the procedure.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: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: medical device problem code a010402 captures the reportable event of stent migration.Block h10: a wallflex esophageal stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was received fully deployed and expanded.Microscopic inspection found the stent cover was damaged.No other issues were noted to the stent.The reported event of stent migration could not be confirmed because this failure occurred during the procedure and it is not possible to replicate in the laboratory analysis.The damage noted on the stent cover was most likely due to procedural factors encountered during the procedure.It may be that the characteristics of the lesion, handling of the device, the techniques used by the user and normal procedural difficulties during removal of the stent contributed to stent cover damaged.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, stent migration is noted within the manufacturers labeling as a known possible adverse event related to the use of the device.Based on available information, the investigation concluded that the reported event of stent migration is a known potential complication associated with the use of the device in the manufacturers labeling.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.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
• 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: 14654315
• Report Number: 3005099803-2022-03112
• Device Sequence Number: 4905030
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0027384040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 65 KG