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

Model Number	M00513730
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat a 4cm malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, while attempting to deploy the stent, the delivery system encountered resistance and became stuck as 70% of the stent was deployed.Subsequently, the stent was removed from the patient partially covered by the deployment suture with the use of a snare.Upon removal of the device, it was noted that the deployment suture was twisted and knotted, and the stent cover was damaged.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat a 4cm malignant esophageal stenosis during a stent placement procedure performed on april 15, 2024.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, while attempting to deploy the stent, the delivery system encountered resistance and became stuck as 70% of the stent was deployed.Subsequently, the stent was removed from the patient partially covered by the deployment suture with the use of a snare.Upon removal of the device, it was noted that the deployment suture was twisted and knotted, and the stent cover was damaged.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6) hospital.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf impact code f2301 captures the use of a snare to remove the stent.Block h11: an ultraflex esophageal delivery system was received for analysis; the stent was not returned.No problems with the delivery system were noted during visual inspection.The reported events of stent partially deployed, stent deployment suture knotted, and stent cover damaged/defective were not confirmed.Analysis of the available information, product analysis of the returned device, and product record review were unable to identify any evidence of the alleged problems.There is no indication of what the customer reported because the stent was not returned.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Additional Manufacturer Narrative
Block e1: the initial reporter's facility name is (b)(6) hospital.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a04 captures the reportable event of stent cover damaged.Imdrf impact code f2301 captures the use of a snare to remove the stent.

• 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: 19269464
• Report Number: 3005099803-2024-02140
• Device Sequence Number: 15310925
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• 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): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2025
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0031308900
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 55 KG