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)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esopageal ng distal release covered stent and delivery system were returned for analysis.Visual examination of the returned device found the deployment suture was returned raveled in the partially deployed section of the stent and stent loops were bent.Functional examination was performed; the deployment suture was unraveled and by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.By retracting the finger ring, the crocheted suture that binds to the delivery system was released gradually and the stent was deployed.The outer diameter (od) of the stent and the stent length were measured and were 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 as the stent was received partially deployed on the delivery system.The investigation concluded that the reported event was likely due to the factors encountered during the procedure.It may be that the reported tight thread contributed to the stent partially deployed in the patient.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for 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 manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per 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 in the esophagus to treat an esophageal cancer during an esophageal self-expanding metal stent (sems) placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was partially deployed inside the patient.The black stent deployment suture was not releasing and very tight.The stent was removed from the patient partially deployed on the delivery system and another ultraflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on investigation result which revealed 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: 10822295
• Report Number: 3005099803-2020-05230
• Device Sequence Number: 14372793
• 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): 11/11/2020

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: 01/22/2022
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0025088788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1