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

Model Number M00513730

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 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code (b)(4) is being used to capture the reportable issue of aborted/cancelled procedure.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 june 03, 2021 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a 4 cm malignant stricture in the esophagus due to esophageal cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent deployment suture got stuck and the stent was unable to fully deploy.The stent was partially deployed on the delivery system when it was removed from the patient.Reportedly, the procedure was not completed as another stent of the same size was unavailable.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 h6: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual inspection was performed and it was noted that the shaft was slightly bent.The crocheted suture was wrapped around the shaft.During functional inspection, it was not possible to deploy the stent by pulling the finger ring due to the wire suture wrapped around the shaft.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed as the stent was received partially deployed and could not be deployed during functional inspection.It is possible that the factors encountered during the procedure limited the performance of the device contributing to the observed failure of shaft bent.Handling and manipulation of the device during the attempted deployment may have caused the observed event of shaft bent.The reported event of stent partially deployed was traced to the manufacturing process.The stent could not gradually release from the delivery system because the wire suture was not returned in a straight line.An investigation to address this issue is in progress.The stent could not be released from the shaft during the normal process; therefore, a review and analysis of all available information indicated the most probable cause is manufacturing deficiency.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.Block h11: correction to block e: initial reporter information based on the review of the complaint.

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 4 cm malignant stricture in the esophagus due to esophageal cancer during a stent placement procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was dilated prior to stent placement.During the procedure, the stent deployment suture got stuck and the stent was unable to fully deploy.The stent was partially deployed on the delivery system when it was removed from the patient.Reportedly, the procedure was not completed as another stent of the same size was unavailable.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: 12050443
• MDR Text Key: 257845169
• Report Number: 3005099803-2021-03046
• 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: 09/13/2021

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: 02/09/2022
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0025181341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68