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

Model Number M00564760

Device Problems Unraveled Material (1664); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on june 08, 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a tumor in the left main bronchus during a tracheobronchial stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the stent was deployed; however, after placement the physician used a bronchoscope to check the stent and felt that the stent was not fully expanded.The stent was removed and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient was reported to be stable.A photo of the complaint device provided by the complainant after the procedure shows the stent partially unraveled and the stent not fully expanded.Note: despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become unavailable, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation on (b)(6), 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a tumor in the left main bronchus during a tracheobronchial stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the stent was deployed; however, after placement the physician used a bronchoscope to check the stent and felt that the stent was not fully expanded.The stent was removed and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient was reported to be stable.A photo of the complaint device provided by the complainant after the procedure shows the stent partially unraveled and the stent not fully expanded.Note: despite efforts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become unavailable, a supplemental report will be submitted.

Manufacturer Narrative

Block h6: problem code 1664 captures the reportable event of stent unraveled material.Problem code 3270 captures the reportable event of stent failure to expand.Block h10: investigation results an ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was not fully expanded and the stent wire unraveled.The outer diameter of the stent was measured and was found to be within specification.No other issues with the stent was noted.The reported event of stent failure to expand and stent unraveled material were confirmed.The investigation concluded that it is possible when the stent was placed and at moment when the user removed the bronchoscope, the stent unraveled and could not fully expand.It is possible when the stent was placed and at the moment when the physician removed the bronchoscope the stent was unraveled and for this reason the stent could not expand during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause adverse event related to procedure.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/ 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
• MDR Report Key: 10213961
• MDR Text Key: 197144110
• Report Number: 3005099803-2020-02454
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0024005896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 56