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

Model Number	M00513850
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
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
Initial reporter's address: (b)(6).(b)(4) captures the reportable event of a partially deployed ultraflex esophageal proximal release covered stent.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat cancer in the lower esophagus during an upper endoscopy with esophageal stent placement procedure performed on (b)(6) 2020.According to the complainant, during preparation, post patient sedation, it was noticed that the stent was partially deployed without manipulation.Reportedly, there were no issues noted with the packaging.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 at the conclusion of the procedure was reported to be stable.A photo of the device provided by the complainant before the procedure shows the stent was partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on june 02, 2020 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat cancer in the lower esophagus during an upper endoscopy with esophageal stent placement procedure performed on (b)(6) 2020.According to the complainant, during preparation, post patient sedation, it was noticed that the stent was partially deployed without manipulation.Reportedly, there were no issues noted with the packaging.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 at the conclusion of the procedure was reported to be stable.A photo of the device provided by the complainant before the procedure shows the stent was partially deployed.
Additional Manufacturer Narrative
Block e1: initial reporter's address 1: (b)(6).Block h6: device problem code 2906 captures the reportable event of a partially deployed ultraflex esophageal proximal release covered stent.Block h10: an ultraflex esophageal ng proximal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent was received partially deployed at the proximal section.The shaft was kinked approximately 35 cm from the tip of the delivery system.The stent was inspected and the loops of the stent were bent at the distal section.Functional evaluation revealed the stent was deployed without resistance by retracting the finger ring and gradually releasing the stent from the delivery system.The outer diameter (od) of the stent was measured and was 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 kink noted on the delivery system was likely a result of excessive force applied to the device during use.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 during the procedure, limited the performance of the device and contributed to the stent partial deployment.Additionally, the loops of the stent were bent; however, there is no sufficient information about what could be the cause.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.

• 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: 10184094
• Report Number: 3005099803-2020-02415
• Device Sequence Number: 14129874
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Followup
• Report Date (Section B): 08/13/2020

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: 12/18/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0023104556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR