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

Model Number	M00513750
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2020
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a malignant stricture in the esophagus during an upper gastrointestinal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was difficult to deploy.The physician applied force and the stent eventually deployed; however, during catheter removal, the stent came out of the patient's mouth along with the delivery system.The procedure was completed with a different device.There were no patient complications reported 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: problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: an ultraflex esophageal ng distal release covered stent was received for analysis; the delivery system was not returned.A media inspection of the photo provided by the complainant noted that the stent was completely deployed and fully expanded.Visual examination of the returned device found the loops of the stent were bent.The outer diameter (od) and length of the stent were measured and were found to be within specification.No other issues were noted to the stent.The reported events of stent difficult to deploy and delivery system difficult to remove could not be confirmed; these failures occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, 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 anatomy of the patient (tight) could have caused the physician to feel resistance while applying force, which limited the performance of the device.Additionally, there is not enough sufficient information of what could be the cause of the stent loops bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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 ifu (instructions for use) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex esophageal ng distal release covered stent was implanted to treat a malignant stricture in the esophagus during an upper gastrointestinal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was difficult to deploy.The physician applied force and the stent eventually deployed; however, during catheter removal, the stent came out of the patient's mouth along with the delivery system.The procedure was completed with a different device.There were no patient complications reported 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: 10803542
• Report Number: 3005099803-2020-05110
• Device Sequence Number: 2917500
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 07/25/2021
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0024170274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 70