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

Model Number M00517440

Device Problems Device Markings/Labelling Problem (2911); Material Integrity Problem (2978)

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

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an agile esophageal fully covered stent was to be implanted in the esophagus to treat a 4cm esophageal cancer during an esophagogastroduodenoscpopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was successfully deployed inside the patient; however, the physician noticed that the proximal and distal end of the stent were not covered with silicone coating.The physician believed that the stent implanted was a partially covered stent rather than a fully covered stent as indicated on the label.Additionally, the stent cover was damaged with 3 to 5 holes in it.The stent was removed from the patient with grasping forceps and a different device was implanted to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: AGILE ESOPHAGEAL
• 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: 11793705
• MDR Text Key: 249620256
• Report Number: 3005099803-2021-02033
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729973065
• UDI-Public: 08714729973065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00517440
• Device Catalogue Number: 1744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• 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
• Patient Outcome(s): Required Intervention