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

Model Number	M00513750
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal ng 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 loops of the stent were bent.The shaft was kinked in several section.Functional examination was performed and the stent was gradually deployed by retracting the finger ring the crocheted suture that binds the stent to the delivery system shaft.The outer diameter (od) and length of the stent were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported events of stent partially deployed and shaft bent were confirmed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated and/or the anatomy of the patient's tight anatomy, limited the performance of the device and contributed to the stent partially deployed and the kink on the shaft.Additionally, there is not enough sufficient information of what could be the cause of the stent loops bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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 a malignant middle esophageal stricture during an upper gastrointestinal (ugi) with esophageal stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was attempted to be deployed; however, the stent deployment suture could not be pulled which caused the catheter to bend and the stent failed to deploy.The stent was removed from the patient partially deployed on the delivery system.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.A photo of the device provided by the complainant shows that the stent was partially deployed and the shaft was bent.Note: this event has been deemed a mdr-reportable event based on 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: 10573268
• Report Number: 3005099803-2020-04122
• Device Sequence Number: 14344894
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0024170274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 70