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	07/05/2020
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 on the delivery system and stent loops were bent.Functional evaluation revealed that it was possible to deploy the stent by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand and gradually releasing the stent without problems.The outer diameter (od) and the length of the stent were measured and were found to be within specifications.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 reported event was likely due to factors encountered during the procedure.It may be how the device was handled or manipulated and the physician may have pulled the wire, limited the performance of the device and contributed to the reported event of stent partially deployed.Additionally, the loops of the stent were bent; however, this failure is not related with the reported event and there is not sufficient information about what could be the cause of the bent stent loops.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, 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 to treat a stenosis in the esophagus during esophageal stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure and outside the patient, the physician noticed that the tip of the stent was partially deployed.Reportedly, the stent was never introduced inside the patient.The procedure was completed with another ultraflex esophageal stent.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: 10413393
• Report Number: 3005099803-2020-03341
• Device Sequence Number: 2409737
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/17/2020

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: 11/27/2021
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0024845175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60