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

Model Number	M00513740
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.
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 malignant 8 cm esophageal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was then removed from the patient partially deployed on the delivery system.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
Blocks b5, d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information received on november 13, 2023 and december 5, 2023.Block h6: imdrf device code a15 captures the reportable event of stent partial deployment.Block h10: the ultraflex esophageal ng distal covered stent and delivery system were received for analysis.Visual inspection found that the stent was fully expanded and deployed from the delivery system.No damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of stent partial deployment because the stent was returned fully expanded and deployed from the delivery system.Additionally, the device met all the manufacturing requirements, and it passed the visual and dimensional inspections during the product analysis.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.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 that an ultraflex esophageal ng distal covered stent was to be implanted in the esophagus to treat a malignant 8 cm esophageal stenosis during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was then removed from the patient partially deployed on the delivery system.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 information received on december 5, 2023: it was reported that the physician attempted to deploy the stent outside the patient after the procedure, and the stent was able to fully deploy and expand.

• 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: 17872668
• Report Number: 3005099803-2023-05299
• Device Sequence Number: 7028396
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• 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): 12/08/2023

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: 09/23/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0028072324
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 58 KG