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

Model Number	M00514240
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal ng proximal release covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was fully cover and undeployed.The shaft was slightly bent, and the loops of the stent were noted to be bent inward.Functional examination was performed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.By retracting the finger ring the crocheted suture that binds to the delivery system shaft, the stent was gradually released from the delivery system, the stent was release without problems.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent.The reported event of stent failure to deploy was not confirmed; the stent was deployed without resistance.The investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that the technique used the by the user trying to deploy the stent, could have caused the resistance felt during the procedure and for this reason the stent failed to deploy and the shaft was slightly bent.Additionally, the stent loops were bent; however, there is insufficient information about what could be the cause for this failure.Therefore, a review and analysis of all available information indicated the most probable cause of the reported event 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, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on october 12, 2020 that an ultraflex esophageal ng proximal release covered stent was to be implanted in the esophagus to treat an esophageal stenosis during stenting procedure performed on (b)(6) 2020.According to the complainant, the stent failed to deploy.Reportedly, the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent loops were bent.

• 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: 11131845
• Report Number: 3005099803-2020-06620
• Device Sequence Number: 11830833
• Product Code: ESW
• UDI-Device Identifier: 08714729716105
• UDI-Public: 08714729716105
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 01/07/2021

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: 07/14/2022
• Device Model Number: M00514240
• Device Catalogue Number: 1424
• Device Lot Number: 0025711297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1