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

Model Number M00513730

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on march 17, 2022 that an ultraflex esophageal covered distal release stent was to be implanted to treat a malignant stricture in the esophagus during a stent placement procedure performed on (b)(6) 2022.During the procedure, the tip of the stent was kinked and there was difficulty in advancing through the scope.The procedure was completed with another ultraflex esophageal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: medical device problem code a04 captures the reportable event of tip kinked.Block h10: an ultraflex esophageal distal released covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection found the deployment suture broken.The tip was inspected and no problems were found.No other issues were noted to the stent and delivery system.The reported event of tip damaged/defective was not confirmed as no problems were noted on the tip of the stent.Product analysis could not confirm the reported event of device difficult to advance as the event occurred during the procedure and could not be functionally/visually verified.It is likely that the manipulation of the deployment suture during the procedure limited the performance of the device and contributed to the observed problems of stent partially deployed and stent deployment suture broken.It may be that demonstrating excessive force during handling or usage and forcing the device against significant resistance caused device damage or loss of functionality which result in the stent being unable to deploy.Therefore, 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.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on march 17, 2022 that an ultraflex esophageal covered distal release stent was to be implanted to treat a malignant stricture in the esophagus during a stent placement procedure performed on march 15, 2022.During the procedure, the tip of the stent was kinked and there was difficulty in advancing through the scope.The procedure was completed with another ultraflex esophageal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• 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: 14042638
• MDR Text Key: 288797812
• Report Number: 3005099803-2022-01760
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091816
• 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,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0025382460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 70 KG