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

Model Number M00513720

Device Problems Device Markings/Labelling Problem (2911); Positioning Problem (3009)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

The patient's exact age was not reported, however, the patient was reported to be under the age of 18.(b)(6).(b)(4).The complainant indicated that the stent remains implanted but the delivery system will be available for return.However, 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 uncovered stent was implanted in the lower esophagus to treat an approximately 6 - 7cm esophageal cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent released from the proximal end and was deployed in an incorrect location.The stent remains implanted and another ultraflex esophageal stent of a different size was implanted over the original stent to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the label indicated on the device was a distal release stent; however, the stent released proximally.

Manufacturer Narrative

Block a2: the patient's exact age was not reported, however, the patient was reported to be under the age of 18.Block e1: the initial reporter's city, state/province, postal code: (b)(6).Block h6: medical device problem code a2101 captures the reportable event of label incorrect one used.Medical device problem code a1502 captures the reportable event of stent positioning issue.Block h10: an ultraflex esophageal delivery system was received for analysis; the stent was not returned.Visual inspection was performed and it was found that the shaft was indicated as a distal release device.No damages were noted to the shaft.The reported events of stent positioning issue and label incorrect one used were not confirmed; the failures occurred during the procedure and it is not possible to replicate in the laboratory of analysis.The shaft was returned and was indicated as a distal release device.Taking all available information, there is no indication of what the customer reported as only the shaft was returned and the stent was not returned as it was deployed during the procedure.The investigation concluded that, without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of the event.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 instructions for use (ifu)/ product label.Additionally, stent positioning issue is a reported adverse event known and documented in the labeling.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex esophageal ng distal uncovered stent was implanted in the lower esophagus to treat an approximately 6 - 7cm esophageal cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent released from the proximal end and was deployed in an incorrect location.The stent remains implanted and another ultraflex esophageal stent of a different size was implanted over the original stent to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the label indicated on the device was a distal release stent; however, the stent released proximally.

• 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: 11516257
• MDR Text Key: 246847140
• Report Number: 3005099803-2021-01135
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716143
• UDI-Public: 08714729716143
• 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: 04/22/2021

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: 09/17/2022
• Device Model Number: M00513720
• Device Catalogue Number: 1372
• Device Lot Number: 0026030779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1