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

Model Number	M00513750
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter facility name is (b)(6).Imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat an 11cm malignant tumor during an esophageal stent implantation procedure performed on (b)(6) 2023.Both ends of the patient's lesion were occluded.The patient anatomy was dilated with a balloon catheter prior to stent placement.During the procedure, the ultraflex esophageal stent was unable to be deployed.The stent was removed from the patient partially covered with stent deployment suture.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent was partially deployed inside the patient.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was returned partially deployed.Visual examination of the returned device did not find any damages to the stent, delivery system and deployment suture.Functional inspection was performed by holding the handle hub in the palm of one hand and retracting the finger ring with the other hand.Buy retracting the finger ring, the crocheted suture that binds the stent to the delivery system unravel, and gradually released the stent from the delivery system.Product analysis confirmed the reported device malfunction of stent partially deployed.Most likely procedural factors encountered during the procedure, such as lesion characteristics, handling of the device, the techniques used by the user when trying to deploy the stent, limited the performance of the device and contributed to partial stent deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on january 13, 2023, that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat an 11cm malignant tumor during an esophageal stent implantation procedure performed on (b)(6), 2023.Both ends of the patient's lesion were occluded.The patient anatomy was dilated with a balloon catheter prior to stent placement.During the procedure, the ultraflex esophageal stent was unable to be deployed.The stent was removed from the patient partially covered with stent deployment suture.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent was partially deployed inside the patient.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: 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: 16322341
• Report Number: 3005099803-2023-00386
• Device Sequence Number: 7993421
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0027866542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 60 KG