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

Model Number	M00513850
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal proximal release stent and delivery system were received for analysis.Visual inspection found the stent was returned partially deployed.Functional examination was performed by actuating the delivery system (pulled the finger ring with the deployment suture), and the stent was able to fully deploy.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy was confirmed as the stent was returned partially deployed.The investigation concluded that the reported event was most likely due to procedural and/or anatomical factors encountered during the procedure.Additionally, the lot number of the device involved during the procedure was used after the expiration date.The device has exceeded the period of time/date recommended by the manufacturer for storing the device without a degradation in quality.Therefore, a review and analysis of all available information indicated the most probable cause is shelf life/expiration date exceeded.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 ultralfex esophageal proximal release covered stent was to be implanted to treat an esophageal cancer during an esophageal stent placement procedure performed on (b)(6) 2021.During the procedure, the stent could not be deployed.The stent was fully covered by the deployment suture when it was removed from the patient.The procedure was completed with another ultraflex esophageal stent.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.Note: this complaint has been deemed mdr reportable based on the investigation result of stent partially deployed.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13361560
• Report Number: 3005099803-2022-00221
• Device Sequence Number: 14637124
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 05/28/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0022178355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 50 KG