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

Model Number M00513730

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 august 15, 2020 that an ultraflex esophageal distal covered stent was implanted to treat a 3cm malignant stricture in the middle of the esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed; however, post stent deployment, it was noted that the stent failed to expand.After 48hrs, x-ray imaging was done and it was observed that the stent was still unable to fully expand.Reportedly, a cre balloon was used to expand the stent.The stent remains implanted and the procedure was completed.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 a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: patient code 3191 captures the additional intervention performed to expand the stent.Device problem code 3270 captures the reportable event of stent failed to expand.Block h10: an ultraflex esophageal distal release delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the shaft was kinked in several sections.No other issues were noted to the delivery system.The reported event of stent failure to expand was not confirmed as the stent was not returned.The kink noted on the delivery system was most likely a result of an excessive force applied to the device during stent deployment.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure may be due to factors encountered during the procedure.It may be that how the device was handled or manipulated during the procedure contributed to stent failure to expand.However, there was no confirmation on what the customer indicated because the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.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 directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on august 15, 2020 that an ultraflex esophageal distal covered stent was implanted to treat a 3cm malignant stricture in the middle of the esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed; however, post stent deployment, it was noted that the stent failed to expand.After 48hrs, x-ray imaging was done and it was observed that the stent was still unable to fully expand.Reportedly, a cre balloon was used to expand the stent.The stent remains implanted and the procedure was completed.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
• MDR Report Key: 10488794
• MDR Text Key: 205899045
• Report Number: 3005099803-2020-03728
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0024047208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Manufacturer Received: 08/15/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention