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

Model Number M00513730

Device Problems Positioning Failure (1158); Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the loops of the stent were bent.The tip of the shaft was cut.Functional examination was performed by holding the hub in the palm of one hand, grasping and retracting the finger ring with the other hand.By retracting the finger ring, the crocheted suture that binds to the delivery system shaft released the stent gradually.The outer diameter (od) of the stent and 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 was not confirmed; during functional examination, the stent was released from the delivery system without any resistance.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be the techniques used by the user and/or the anatomy of the patient, limited the performance of device and could have caused the resistance felt during deployment and contributed to stent partial deployment.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.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 that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant stenosis in the esophagus during a stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent failed to deploy and the stent was fully covered by the stent deployment suture when removed from the patient.The procedure was completed with another ultraflex esophageal stent.Reportedly, the tip of the shaft was cut after the removal of the stent from the patient.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.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent loops were bent.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11067100
• MDR Text Key: 226299981
• Report Number: 3005099803-2020-06413
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

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: 06/25/2021
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0024016580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 73