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

Model Number M00513740

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

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon 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 esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to fully deployed.The stent was removed from the patient partially deployed on the delivery system.The procedure was not completed as another stent of the same size was unavailable.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/canceled procedure.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual examination of the returned device did not find any damages or issues to the stent and delivery system.The reported event of stent partially deployed was not confirmed; the stent was received fully deployed and expanded.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event as there is no confirmation on what the customer indicated.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.

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 esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to fully deployed.The stent was removed from the patient partially deployed on the delivery system.The procedure was not completed as another stent of the same size was unavailable.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.

• 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: 12172833
• MDR Text Key: 261689466
• Report Number: 3005099803-2021-03511
• 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: 08/31/2021

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: 02/25/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0026870627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1