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

Model Number	M00513750
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal ng distal release covered stent and delivery system were received for analysis.The stent was returned partially deployed.Visual examination was performed and it was found that the loops of the stent were bent.Functional evaluation revealed the stent was deployed by holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand and gradually released the stent with no resistance.The outer diameter and the stent length were measured and found to be within specification.The outer diameter of the shaft was measured and found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed; however, the reported event of delivery system difficult to cross lesion was not confirmed.The delivery system was measured and it passed the dimensional inspection.A labeling review was performed, and from the information available, the device was used in a manner inconsistent with the directions for use (dfu).The dfu cited, "warning: visually inspect the system for any sign of damage.Do not use if the system has any visible signs of damage".However, according to the complainant, the device was attempted to be used despite the partial deployment noted during unpacking.The stent's partial deployment may have caused the difficulty in crossing the lesion.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted to treat a malignant tracheoesophageal fistula during an upper gastrointestinal with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, while unpacking the stent, it was noted that the stent was partially deployed even without manipulation.The physician attempted to advance the device into the patient but was unable to cross the stricture.The stent was removed and it was noted that two uncovered cells were opened vertical to the catheter making it difficult to advance through the stricture.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.Note: according to the complainant, the ultraflex esophageal stent was found partially deployed during unpacking and the physician attempted to advance the stent through the stricture.Per the ultraflex esophageal ng covered stent system directions for use (dfu), " visually inspect the system for any sign of damage.Do not use if the system has any visible signs of damage".The stent is not indicated to be used if visibly damaged.This event has been deemed an mdr reportable event based on the investigation results which revealed that 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: 10609918
• Report Number: 3005099803-2020-04316
• Device Sequence Number: 2802878
• 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
• Report Date (Section B): 09/30/2020

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: 02/16/2022
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0025219671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 54