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

Model Number M00564570

Device Problems Material Deformation (2976); Positioning Problem (3009)

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

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not 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 (b)(6) 2021 that an ultraflex tracheobronchial uncovered distal release stent was to be implanted in the trachea to treat a malignant bronchial lesion during a stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully deployed inside the patient; however, under computed tomography (ct) scan and endoscopic imaging, it was noticed that the stent was slightly deviated from the target location.The stent was also knotted and crumpled and could not be straightened out during adjustment with foreign body forceps.The stent was removed from the patient using forceps and a non-bsc stent was implanted 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.

Event Description

It was reported to boston scientific corporation on march 09, 2021 that an ultraflex tracheobronchial uncovered distal release stent was to be implanted in the trachea to treat a malignant bronchial lesion during a stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was successfully deployed inside the patient; however, under computed tomography (ct) scan and endoscopic imaging, it was noticed that the stent was slightly deviated from the target location.The stent was also knotted and crumpled and could not be straightened out during adjustment with foreign body forceps.The stent was removed from the patient using forceps and a non-bsc stent was implanted 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.

Manufacturer Narrative

Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a0406 captures the reportable event of stent material deformation.Block h10: an ultraflex tracheobronchial uncovered distal release stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was unraveled and the retention suture was detached.The shaft was returned bent in several sections.No other issues with the stent and delivery system were noted.The reported event of stent positioning issue was not confirmed as it is impossible to replicate the failure in the laboratory of analysis as it occurred during the procedure.The reported event of stent material deformation was not confirmed; however, stent unraveled was noted.It is possible that the retention suture was detached and the stent unraveled during stent removal after it was determined the stent was deployed in the incorrect location and the stent was damaged.The bends noted on the shaft may have been a result of device manipulation after the procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.Additionally, stent positioning issue is noted within the ifu as a known potential adverse event related to the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 11602014
• MDR Text Key: 243340332
• Report Number: 3005099803-2021-01386
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: M00564570
• Device Catalogue Number: 6457
• Device Lot Number: 0023160701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 62