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

Model Number M00513740

Device Problems Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex esophageal distal release covered stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found the shaft bent.A dimensional inspection was performed and the device profile was measured to be within specification.No other problems were noted to the stent and delivery system.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to the patient anatomy (tortuous/ tight) which limited the performance of the device and contributed to the reported event and the stent partial deployment and shaft bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted in the esophagus to treat a malignant esophageal stenosis during an esophageal stent implantation procedure performed on (b)(6), 2022.The patient's anatomy was tortuous.During the procedure, the stent could not cross the stenosis part the stent was removed, and the procedure was completed using a different device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the stent was partially deployed.

• 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: 16059865
• MDR Text Key: 308545389
• Report Number: 3005099803-2022-07729
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2022

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 Expiration Date: 03/16/2023
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0026976558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG