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

Model Number	M00513730
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted in the mid esophagus to treat a 5cm stricture due to cancer during a metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, it got stuck and was unable to be fully deployed.The stent was removed from the patient partially deployed and a different device was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted in the mid esophagus to treat a 5cm stricture due to cancer during a metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, it got stuck and was unable to be fully deployed.The stent was removed from the patient partially deployed and a different device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal distal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent partially deployed.Functional testing was performed by pulling the finger ring, and the stent was deployed without problems; no resistance was felt.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that this was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• 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: 18132886
• Report Number: 3005099803-2023-06183
• Device Sequence Number: 18037703
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: 08714729716150
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 04/07/2024
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Device Lot Number: 0029194218
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 58 KG
• Patient Race: Asian