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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on december 18, 2020 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 5cm esophageal stricture due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent could not be deployed inside the patient.Reportedly, the stent was removed from the patient partially deployed on the delivery system.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.
Additional Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of an ultraflex esophageal ng proximal release stent partially deployed.Block h10: an ultraflex esopageal ng proximal release covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was returned partially deployed.The shaft of the delivery system was returned kinked.Functional examination was performed by retracting the finger ring and the crocheted suture that binds to the delivery shaft, and was successful gradually released the stent from the delivery system.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 that the technique used by the user during deployment could have caused the stent to be partially deployed on the delivery system.Additionally, the amount of force applied to the delivery system during deployment could have caused the kink observed in the delivery shaft.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 instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation on december 18, 2020 that an ultraflex esophageal ng proximal release covered stent was to be implanted to treat a 5cm esophageal stricture due to esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent could not be deployed inside the patient.Reportedly, the stent was removed from the patient partially deployed on the delivery system.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.

• 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: 11141971
• Report Number: 3005099803-2020-06659
• Device Sequence Number: 631913
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 03/28/2021
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0023561827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 58