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

Model Number M00514240

Device Problem Activation Failure (3270)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Vomiting (2144)

Event Date 06/21/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022, that an ultraflex esophageal ng proximal release covered stent was implanted in the esophagus to treat an 8cm malignant stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.The patient's anatomy was tortuous and was dilated prior to stent placement.On (b)(6) 2021, post stent placement, the patient presented hematemesis and hemoglobin drop.Consequently, a repeat esophagogastroduodenoscopy (egd) procedure was performed, and it was found that the ultraflex esophageal stent was unable to expand and a stent erosion hemorrhage at the distal end was noted.The ultraflex esophageal stent was removed from the patient with forceps and the bleeding was resolved on its own and the procedure was completed.The patient's condition at the conclusion of the procedure was reported to have improved.

Manufacturer Narrative

(b)(4).

• 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: 15609398
• MDR Text Key: 301813904
• Report Number: 3005099803-2022-06077
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716105
• UDI-Public: 08714729716105
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: M00514240
• Device Catalogue Number: 1424
• Device Lot Number: 0026937154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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
• Patient Outcome(s): Required Intervention