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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 august 20, 2021 that an ultraflex esophageal ng covered proximal release stent was to be used to treat a 4-5 cm stricture due to tumors in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent partially deployed.The stent was removed partially deployed on the delivery system and another ultraflex esophageal stent was implanted to complete the procedure.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
Blocks d4 and h4 have been updated with the additional information received on september 17, 2021.Block e1: initial reporter address 2: (b)(6).Block h6: medical device problem code a15 captures the reportable event of a partially deployed ultraflex esophageal proximal release covered stent.Block h10: an ultraflex tracheobronchial covered proximal release stent and delivery system were received for analysis.Visual examination of the returned device found the stent partially deployed.Functional inspection was performed and the stent was able to fully deploy without resistance.No other issues with the stent and delivery system were noted.The reported event of stent partially deployed was confirmed via visual examination.Taking all available information into consideration, the investigation concluded that the reported event and observed failure were likely due to factors encountered during the procedure.Additionally, the device was also used past its expiry date.The expiration date was june 21, 2020; however, the device was used on august 19, 2021.The device had 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 on (b)(6) 2021 that an ultraflex esophageal ng covered proximal release stent was to be used to treat a 4-5 cm stricture due to tumors in the esophagus during an esophageal stent implantation procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent partially deployed.The stent was removed partially deployed on the delivery system and another ultraflex esophageal stent was implanted to complete the procedure.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: 12459669
• Report Number: 3005099803-2021-04719
• Device Sequence Number: 17160531
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 06/21/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0022288561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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