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

Model Number	M00513840
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on december 12, 2019 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a stricture due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was attempted to be deployed; however, the stent was not able to be fully released.The device was removed from the patient partially deployed.The procedure was completed with another ultraflex tracheobronchial 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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a stricture due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was attempted to be deployed; however, the stent was not able to be fully released.The device was removed from the patient partially deployed.The procedure was completed with another ultraflex tracheobronchial 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.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: (b)(6).Block h6: problem code 2906 captures the reportable event of a partially deployed ultraflex esophageal ng proximal release covered stent.Block h10: an ultraflex esophageal ng proximal release covered stent, delivery system and deployment suture were returned for analysis.Visual examination of the returned device found the stent was received deployed and expanded.The stent was measured to be within specifications.No other issues with the stent and delivery system were noted.The initial report that the stent was partially deployed when removed from the patient could not be confirmed based on the condition of the returned device; however, it was confirmed by the complainant that the physician deployed the stent outside the patient prior to returning the device for analysis.Taking all available information into consideration, the investigation concluded that the reported event is likely due to procedural factors such as handling of the device, the technique used by the user and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, 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.

• 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: 9559506
• Report Number: 3005099803-2019-06372
• Device Sequence Number: 2460779
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 10/02/2020
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0022738898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 55