MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564830

Device Problem Activation Failure (3270)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted in the esophagus to treat a malignant esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, the stent did not fully expand while still on the delivery system.The physician waited for an additional two minutes; however, the stent still did not fully expand.The physician then decided to remove the stent together with the delivery system and completed the procedure using another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.A photo of the device provided by the complainant shows that the stent did not fully expand and was still on the delivery system.

Manufacturer Narrative

Block e1: initial reporter first name: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.

Event Description

It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial distal release covered stent was to be implanted in the esophagus to treat a malignant esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was slightly tortuous and was not dilated prior to stent placement.During the procedure, the stent was deployed; however, the stent did not fully expand while still on the delivery system.The physician waited for an additional two minutes; however, the stent still did not fully expand.The physician then decided to remove the stent together with the delivery system and completed the procedure using another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.A photo of the device provided by the complainant shows that the stent did not fully expand and was still on the delivery system.

Manufacturer Narrative

Block e1: initial reporter first name: (b)(6).Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Block h10: an ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent not fully expanded and the shaft bent in different sections.Functional inspection was performed, the stent did not expand even when it was submerged in warm water for 15 minutes.A media inspection was performed of a photo provided by the complainant, and it was observed that the stent was not fully expanded.No other problems were noted to the delivery system.The investigation concluded that the observed failure of shaft bent in different sections were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and/or the technique used by the physician, limited the performance of the device and contributed to the observed failure.The reported event of stent failure to expand was confirmed.Considering the condition of the returned device, the failure to expand of the stent cover is consistent with the thermal-mechanical failures of stent covers exposed to temperatures exceeding the recommended temperatures.Therefore, based on this information, the damage can be attributed to transport and storage conditions.For this reason, the event is classified as "cause traced to transport/storage" because, the problems traced to the inappropriate transport or storage of the device.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.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 17326846
• MDR Text Key: 319227013
• Report Number: 3005099803-2023-03824
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Model Number: M00564830
• Device Catalogue Number: 6483
• Device Lot Number: 0029326648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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