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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number M00564810
Device Problems Break (1069); Positioning Failure (1158); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the trachea to treat a tracheoesophageal fistula during a tracheobronchial implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not dilated prior to stent placement.During the procedure, the stent deployment suture fractured and the stent could not be deployed.The stent fully covered by the stent deployment suture when it was removed from the patient.Reportedly, the procedure was not completed due to this event and the procedure will be rescheduled.In the physician's assessment, the patient may have not been able to endure a prolonged procedure.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted in the trachea to treat a tracheoesophageal fistula during a tracheobronchial implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not dilated prior to stent placement.During the procedure, the stent deployment suture fractured and the stent could not be deployed.The stent fully covered by the stent deployment suture when it was removed from the patient.Reportedly, the procedure was not completed due to this event and the procedure will be rescheduled.In the physician's assessment, the patient may have not been able to endure a prolonged procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: medical device problem code a27 is being used to capture the reportable issue of aborted/canceled procedure.Block h10: an ultraflex tracheobroncial covered stent and delivery system were received for analysis.The stent was returned completely deployed.Visual examination of the returned device found the deployment suture was broken and was completely separated from the shaft.The shaft was bent in two sections.No other issues with the stent and delivery system were noted.The reported event of stent failure to deploy was confirmed although functional evaluation was not performed.It can be observed that the shaft was kinked, the stent deployment suture was broken and was completely detached from the delivery system which could have resulted in stent failure to deploy.The investigation concluded that the reported events and the observed failures were most likely due to anatomical and/or procedural factors encountered during the procedure which limited the performance of the device and contributed to stent failure to deploy and stent deployment suture break.It might be that handling and manipulation of the device during use could have lead to the kinks observed in the shaft and difficulty in deploying the stent.Multiple attempts to release the stent could have resulted in stent deployment suture break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
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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 Key11385537
MDR Text Key233790503
Report Number3005099803-2021-00789
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K012883
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/19/2022
Device Model NumberM00564810
Device Catalogue Number6481
Device Lot Number0025376067
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2021
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age48 YR
Patient Weight75
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