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

Model Number M00513740

Device Problems Activation Failure (3270); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on march 19, 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a stricture in the lower esophagus during an esophageal stenting procedure performed on (b)(6) 2020.Reportedly, the stricture was caused by esophageal carcinoma.According to the complainant, during the procedure, the stent was able to be deployed.However, immediately after the stent placement procedure, a scope was passed and the stent was noticed not fully expanded and the stent moved out from its target location.The stent was removed from the patient with forceps and the procedure was completed with a different device.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 (b)(6) 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a stricture in the lower esophagus during an esophageal stenting procedure performed on.Reportedly, the stricture was caused by esophageal carcinoma.According to the complainant, during the procedure, the stent was able to be deployed.However, immediately after the stent placement procedure, a scope was passed and the stent was noticed not fully expanded and the stent moved out from its target location.The stent was removed from the patient with forceps and the procedure was completed with a different device.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

Blocks d4 and h4 have been corrected based on additional information received on october 21, 2020.Block h6: device problem code 3270 captures the reportable event of stent failure to expand.Device problem code 2907 captures the reportable event of stent migration.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received completely deployed and not fully expanded.Visual inspection was performed and the shaft was found kinked approximately 33cm from the tip of the delivery system.The loops of the stent were bent.Functional examination was performed by submerging the stent in a hot water for 10 minutes and the stent fully expanded.The outer diameter (od) and the length of the stent were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent failure to expand was confirmed; the stent was received not fully expanded.However, during functional examination, the stent fully expanded after 10 minutes submerged in a hot water passing the functional inspection.The reported event of stent migration could not be confirmed because the failure occurred during the procedure and it is not possible to replicate in the laboratory of analysis.The investigation concluded that the reported events were likely due to factors encountered during the procedure and/ or the patient's anatomy, which limited the performance of the device and contributed to stent failure to expand and stent migration.The observed failure of the shaft kinked may be due to the force applied when the physician deployed the stent.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Therefore, a 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 labeling review was performed, and from the information available, this device was used per the instructons for use (ifu) / product label.Additionally, stent migration is listed within the ifu as potential adverse event associated with the used of this device.

• 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: 9939081
• MDR Text Key: 189614537
• Report Number: 3005099803-2020-01532
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0024727171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention