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

Model Number M00513750

Device Problems Failure to Advance (2524); Material Deformation (2976); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An ultraflex esophageal distal release covered stent and delivery system were received for analysis.The stent was returned partially deployed.Visual inspection found the deployment suture rolled up in the shaft.Functional evaluation revealed that it was possible to deploy the stent by unrolling the deployment suture from the shaft and holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.However, the stent was unable to fully expand in one section.No other issues were noted to the stent and delivery system.The reported event of shaft kinked was not confirmed as no damages were found on the shaft.The reported event of delivery system difficult to cross lesion could not be confirmed as this occurred during the procedure and is not possible to replicate in the laboratory of analysis.It is likely that procedural factors such as handling of the device and the technique used by the user limited the performance of the device and contributed to the stent partial deployment.Furthermore, it is likely that the manipulation of the device after the procedure could have caused the deployment suture to become rolled up in the shaft which also led to the stent failure to expand.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted to treat an esophageal carcinoma during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the ultraflex delivery catheter got kinked and was unable to advance through the stricture.The device was removed and a different stent was used to complete the procedure.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: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the ultraflex esophageal stent did not fully expand.

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted to treat an esophageal carcinoma during a stent placement procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the ultraflex delivery catheter got kinked and was unable to advance through the stricture.The device was removed and a different stent was used to complete the procedure.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: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the ultraflex esophageal stent did not fully expand.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code (b)(6)captures the reportable investigation results of ultraflex esophageal stent failed to expand.Block h10: an ultraflex esophageal distal release covered stent and delivery system were received for analysis.The stent was returned partially deployed.Visual inspection found the deployment suture rolled up in the shaft.Functional evaluation revealed that it was possible to deploy the stent by unrolling the deployment suture from the shaft and holding the handle hub in the palm of one hand, grasping and retracting the finger ring with the other hand.However, the stent was unable to fully expand in one section.No other issues were noted to the stent and delivery system.The reported event of shaft kinked was not confirmed as no damages were found on the shaft.The reported event of delivery system difficult to cross lesion could not be confirmed as this occurred during the procedure and is not possible to replicate in the laboratory of analysis.It is likely that procedural factors such as handling of the device and the technique used by the user limited the performance of the device and contributed to the stent partial deployment.Furthermore, it is likely that the manipulation of the device after the procedure could have caused the deployment suture to become rolled up in the shaft which also led to the stent failure to expand.However, there is no indication of what the customer reported because the shaft was received in good condition and the outer diameter of the device was found within specification.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.Block h11: block h10 has been corrected.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: 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: 15545244
• MDR Text Key: 306518894
• Report Number: 3005099803-2022-05833
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: 08714729649113
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: M00513750
• Device Catalogue Number: 1375
• Device Lot Number: 0027347512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1