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

Model Number M00513730

Device Problems Positioning Failure (1158); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus during esophageal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician pulled the black deployment suture, the proximal end of the shaft kinked and the stent could not be deployed.Reportedly, the stent was removed from the patient fully covered with deployment suture and the procedure was not completed.Reportedly, the patient was scheduled for another stent placement; however, the exact date is unknown.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 3191 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 returned for analysis.Visual examination of the returned device found the stent was received partially deployed.The shaft was kinked approximately 28 cm from the tip of the delivery system.The loops of the stent were bent.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received.The outer diameter (od) of the stent and the stent length 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 deploy and shaft kinked were confirmed.The shaft was returned kinked and it was not possible to deploy the stent during functional examination.The investigation concluded that the reported events and the observed failures were likely due to factors encountered during the procedure and/or during the insertion of the device.The physician might have felt some resistance when pulling the black stent deployment suture and for this reason, the shaft may have kinked and the stent was not deployed.Additionally, the stent loops were bent; however, there is insufficient 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.

Event Description

It was reported to boston scientific corporation on october 22, 2020 that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus during esophageal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician pulled the black deployment suture, the proximal end of the shaft kinked and the stent could not be deployed.Reportedly, the stent was removed from the patient fully covered with deployment suture and the procedure was not completed.Reportedly, the patient was scheduled for another stent placement; however, the exact date is unknown.There were no patient complications reported as a result of this event.The patient's condition following 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: 10819607
• MDR Text Key: 225871893
• Report Number: 3005099803-2020-05243
• 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: 12/17/2020

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: 11/24/2021
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0024823948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/27/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 60