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	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Problem code (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 deployment suture was returned raveled in the stent.The shaft was bent in different sections.The loops of the stent were bent.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) of the stent and 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.Taking all available information into consideration, the investigation concluded that the reported event was likely due to factors encountered during the procedure.Most likely during deployment, the physician twisted the shaft contributing to the deployment suture to be raveled at the distal section resulting in the stent to be partially deployed.The observed failure of shaft bent could be the result of the amount of force applied to the device during attempted deployment.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.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted during an esophageal stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatimy was not tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was partially deployed.The procedure was completed with another ultraflex esophageal stent.There were no patient complications 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 a mdr-reportable event based on investigation results which revealed that the stent loops were bent.Please see block h10 for full investigation details.

• 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: 10927285
• Report Number: 3005099803-2020-05767
• Device Sequence Number: 4295029
• 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): 12/01/2020

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: 04/01/2022
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0025431831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1