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

Model Number M00513730

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Initial reporter name and address: healthcare facility details are as below: (b)(6), canada, (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation on november 17, 2022 that an ultraflex esophageal distal covered stent was implanted in the esophagus to treat a malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on an unknown date.The patient's anatomy was not tortuous.During a routine follow-up, a repeat egd procedure was performed and it was noticed that loops of the stent were bent inward.The ultraflex esophageal stent remained implanted and the procedure was completed; however, the physician was concerned that the device problem may lead to obstruction.There were no patient complications reported as a result of this event.Note: a photo of the device implanted inside the patient was provided and it was observed that the loops of the stent were bent inward.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: 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: 15941087
• MDR Text Key: 308205043
• Report Number: 3005099803-2022-07238
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2022

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
• Device Operator: Health Professional
• Device Model Number: M00513730
• Device Catalogue Number: 1373
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1