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

Model Number	M00517460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: the exact implant date is unknown; however, it was reported that the stent was implanted six months ago.The complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon 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 (b)(6) 2021 that an agile esophageal fully covered stent was implanted in the esophagus to treat an esophageal stricture during a stent placement procedure performed six months ago.On (b)(6) 2021, during a scheduled stent removal procedure, after the stent was removed from the patient with forceps, the physician noticed that the metal welds of the stent were separated.The stent removal procedure was successfully completed.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2021 that an agile esophageal fully covered stent was implanted in the esopahagus to treat an esophageal stricture during a stent placement procedure performed six months ago.On (b)(6) 2021, during a scheduled stent removal procedure, after the stent was removed from the patient with forceps, the physician noticed that the metal welds of the stent were separated.The stent removal procedure was successfully completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d6a: the exact implant date is unknown; however, it was reported that the stent was implanted six months ago.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the manufacture and expiration dates are unknown.Block h6: medical device problem code a0401 captures the reportable event of stent break.Block h10: an agile esophageal stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found stent wires were broken.No other issues were noted to the stent.The reported event of stent break was confirmed via visual inspection.The investigation concluded that the reported event of stent break was most likely due to anatomical and/or procedural factors encountered during the procedure.These factors could have contributed to the broken stent wires during the initial placement or during the six months the stent was implanted.Also, it is possible that the stent wires were broken during the removal of the stent with forceps.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.

• Brand Name: AGILE ESOPHAGEAL
• 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: 12863151
• Report Number: 3005099803-2021-06100
• Device Sequence Number: 4571546
• Product Code: ESW
• UDI-Device Identifier: 08714729973089
• UDI-Public: 08714729973089
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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 Model Number: M00517460
• Device Catalogue Number: 1746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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