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

Model Number M00513740

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

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

Event Date 03/27/2021

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 (b)(6) 2021 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 7cm malignant stricture in the esophagus during an upper gastrointestinal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the shaft bent while advancing the stent delivery system over the steel wire.The physician attempted to deploy the stent but only 20% of the stent was released from the delivery system.The stent was removed from the patient partially covered by the deployment suture.The procedure was cancelled due to patient's request and opted to have the procedure done in a different facility.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.

Event Description

It was reported to boston scientific corporation on march 27, 2021 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 7cm malignant stricture in the esophagus during an upper gastrointestinal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the shaft bent while advancing the stent delivery system over the steel wire.The physician attempted to deploy the stent but only 20% of the stent was released from the delivery system.The stent was removed from the patient partially covered by the deployment suture.The procedure was cancelled due to patient's request and opted to have the procedure done in a different facility.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.

Manufacturer Narrative

Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex esophageal stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found that the shaft was kinked approximately 32cm from the tip.No other issues were noted to the stent and delivery system.The reported events of stent partially deployed and shaft kinked were confirmed.Visual examination of the returned device and the media inspection of the photo provided by the complainant showed the shaft was kinked and the stent was partially deployed.It is possible that the factors encountered during the procedure and/or the patient's tight anatomy could have contributed to the kink on the shaft when the physician attempted to deploy the stent.The kink could have caused resistance, limited the performance of the device, contributing to the reported event of stent partial deployment.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 manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11697246
• MDR Text Key: 247725399
• Report Number: 3005099803-2021-01772
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0026419537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Manufacturer Received: 03/27/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 58