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

Model Number	M00514210
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal ng distal release covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received partially deployed.The shaft was returned kinked approximately at 23 cm from the tip of the delivery system and the stent loops were found bent.Functional evaluation revealed the stent was released gradually by retracting the finger ring (crocheted suture).The outer diameter (od) of the stent was measured and was found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that the stent partially deployed and shaft kinked were likely due to procedural factors.It may be how the device was handled or manipulated, or the resistance encountered during the procedure, limited the performance of the device and contributed to the stent deployed partially and the kink on delivery system.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause of this failure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with a different device.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 stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the stent loops were bent.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10454964
• Report Number: 3005099803-2020-03542
• Device Sequence Number: 19713863
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: 08714729121206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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 Expiration Date: 04/29/2021
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 0023716360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1