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

Model Number	M00517240
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's exact age was not reported, however, the patient was reported to be over the age of 18.(b)(4).The device has been received for analysis.Upon completion of the failure 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) 2020 that an agile esophageal partially covered stent was implanted below the cricopharyngeal muscle to treat an esophageal fistula.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.According to the complainant, during the procedure, while attempting to deploy the stent, strong resistance was encountered.Reportedly, the delivery system was in fully deployed position; however, the stent was partially deployed.Reportedly, the stent was partially deployed on the delivery system when it was removed from the patient and the stent was then re-constrained manually.Then the scope and stent were re-inserted back into the patient and the stent was fully deployed.The physician then used a rat tooth forcep to adjust the stent into the correct position and the procedure was completed.After the procedure, a kink in the deployment catheter was noted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that an agile esophageal partially covered stent was implanted below the cricopharyngeal muscle to treat an esophageal fistula.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement procedure.According to the complainant, during the procedure, while attempting to deploy the stent, strong resistance was encountered.Reportedly, the delivery system was in fully deployed position; however, the stent was partially deployed.Reportedly, the stent was partially deployed on the delivery system when it was removed from the patient and the stent was then re-constrained manually.Then the scope and stent were re-inserted back into the patient and the stent was fully deployed.The physician then used a rat tooth forcep to adjust the stent into the correct position and the procedure was completed.After the procedure, a kink in the deployment catheter was noted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block a2: the patient's exact age was not reported, however, the patient was reported to be over the age of 18.Block h6: device problem code 3009 captures the reportable event of stent positioning issue.Block h10: an agile esophageal delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer clear sheath was kinked and twisted.The tip of the outer clear sheath was pushed out.The outer blue sheath was kinked approximately 7cm from the hub handle.The handle was inspection and three marks of deployment indicator was noted.The inner shaft was kinked in several sections.The outer diameter (od) of the delivery system was measured and was found to be within specification.During functional analysis, the guidewire was backloaded and it exits at the distal tip without resistance, the guidewire was also frontloaded and it pass without problems and it exit at the handle as expected.No other issues were noted to the delivery system.The reported event of stent partially deployed, stent difficult to deploy and stent positioning issue were not confirmed.These failures occurred during the procedure and it is not possible to replicate in the laboratory of analysis.A labeling review was performed, and from the information available, the device was used in a manner inconsistent with the instructions for use.Per ifu, "if the positioning of an agile esophageal partially covered stent is not correct and has already been deployed past the reconstrainment limit, continue to fully deploy the stent." however, the complainant reported that the user manually reconstained the partially deployed stent with the delivery system in fully deployed position.The investigation concluded that reported events and the observed failures were likely due to the factors encountered during the procedure.It may be how thedevice was handled or manipulated and the resistance felt during the procedure, which limited the performance of the device.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 revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: AGILE ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10898255
• Report Number: 3005099803-2020-05682
• Device Sequence Number: 2478494
• Product Code: ESW
• UDI-Device Identifier: 08714729972945
• UDI-Public: 08714729972945
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: M00517240
• Device Catalogue Number: 1724
• Device Lot Number: 0025673886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention