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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 M00564910
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
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 tracheal stenosis in the weasand during a tracheal metal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed in the incorrect position.When the physician adjusted the position of the stent, the green retention suture was fractured.The stent was removed and the patient will be re-scheduled to implant another stent.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.
 
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 tracheal stenosis in the weasand during a tracheal metal stent implantation procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed in the incorrect position.When the physician adjusted the position of the stent, the green retention suture was fractured.The stent was removed and the patient will be re-scheduled to implant another stent.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.
 
Manufacturer Narrative
Block h6: problem code 1069 captures the reportable event of stent suture break.Problem code 3009 captures the reportable event of stent positioning problem.Block h10: an ultraflex tracheobronchial distal release covered stent was received for analysis; the delivery system was not returned.The stent was received completely deployed.Visual examination of the returned device found the green retention suture was broken and the stent suture was unraveled.The loops of the stent were found bent.The outer diameter (od) of the stent was measured and was found to be within specification.No other issues were noted to the stent.The reported event of stent suture break was confirmed; the green retention suture was found broken.The reported event of stent positioning issue could not be confirmed because this failure occured during the procedure and it is not possible to replicate in the laboratory.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure or the patient anatomy, limited the performance of the device and could have cause the reported event of stent suture break when the physician adjusted the positon of the stent and pulled the stent suture.Additionally, there is no sufficient information of what could be the cause of the stent loops bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / product label.
 
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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 Key10246849
MDR Text Key198019093
Report Number3005099803-2020-02628
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2019
Device Model NumberM00564910
Device Catalogue Number6491
Device Lot Number0021469890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Date Manufacturer Received08/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight60
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