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

Model Number	M00516730
Medical Device Problem Codes	Positioning Failure (1158); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted to treat an esophageal stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement, procedure performed on (b)(6) 2024.According to the complainant, during the procedure, the proximal stent would not open/expand fully after deployment.The stent was removed, and the procedure was completed with another wallflex esophageal stent.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 and h6 (device code and impact code) have been updated based on the additional information received on november 22, 2024.Blocks d6a implant date, e1 (initial reporter facility name, address, city, state, zip code, phone number, fax) e2, e3, and h6 (additional mfr, narrative) have been corrected.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand imdrf impact code f2301 captures the used of additional device to remove the unexpanded stent.Block h11: a wallflex esophageal fully covered stent and delivery system were received for analysis.Visual inspection revealed that the device was returned fully covered and undeployed.The clear outer sheath was kinked.Functional testing demonstrated that the stent could be deployed without issues and with no resistance by actuating the delivery system.No other damage was observed on the device.Product analysis did not confirm the reported event of stent failure to expand, as the stent was returned undeployed.Based on all available information, the investigation concluded that there was no confirmation of the reported issue.Functional testing related to the stent's deployment was performed, and the stent deployed and expanded as expected.Therefore, a review and analysis of all available information indicate that the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted to treat an esophageal stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement, procedure performed on (b)(6) 2024.According to the complainant, during the procedure, the proximal stent would not open/expand fully after deployment.The stent was removed, and the procedure was completed with another wallflex esophageal stent.There was no patient complications reported as a result of this event.Additional information received on november 22, 2024: it was reported that the stent did not open during deployment.Note: failed stent deployment is unlikely to cause or contribute to a death or serious injury.Therefore, boston scientific no longer considers this to be a reportable event.

• 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: 20249877
• Report Number: 3005099803-2024-04507
• Device Sequence Number: 12588095
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: 08714729778066
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 12/10/2025
• Device Model Number: M00516730
• Device Catalogue Number: 1673
• Device Lot Number: 0034005821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• 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