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

Model Number	M00514250
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on may 16, 2022 that an ultraflex esophageal ng proximal release covered stent was to be implanted in the distal esophagus to treat a 7cm esophageal cancer during an esophageal self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the stent was introduced over the wire and deployment was started.After pulling the stent deployment suture over 2 to 3 cm, resistance was felt and the stent was unable to fully deploy.The stent was removed from the patient partially deployed on the delivery system and the procedure was completed with another ultraflex esophageal stent.The stent was able to be deployed outside the patient after some resistance.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex esophageal ng proximal release covered stent was to be implanted in the distal esophagus to treat a 7cm esophageal cancer during an esophageal self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous.During the procedure, the stent was introduced over the wire and deployment was started.After pulling the stent deployment suture over 2 to 3 cm, resistance was felt and the stent was unable to fully deploy.The stent was removed from the patient partially deployed on the delivery system and the procedure was completed with another ultraflex esophageal stent.The stent was able to be deployed outside the patient after some resistance.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of partially deployed ultraflex esophageal proximal release stent.Block h10: an ultraflex esophageal ng proximal release covered stent and delivery system were received for analysis.The stent was returned completely deployed.Visual examination of the returned device found the stent was deformed in one section due to stent wire unravelling.No other issues to the stent and delivery system were noted.The damaged noted on the stent was most likely due to procedural factors encountered during the procedure.It may be the lesion characteristics, handling of the device, the technique used by the user during removal of stent could have caused the stent wire to unravel.The reported event of stent partially deployed could not be confirmed; the stent was returned fully deployed.There was no confirmation on what the customer indicated due to the condition of the returned device.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 14621671
• Report Number: 3005099803-2022-03058
• Device Sequence Number: 14566914
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 09/14/2023
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0028014752
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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 Sex: Unknown