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

Model Number	M00576640
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; 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 or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be used to treat an approximately 2 cm malignant pulmonological obstruction during a bronchoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, resistance was felt during the attempt deployment.Force was applied in pulling the stent deployment suture, but the stent failed to open.The device was removed from the patient.Reportedly, the physician attempted to deploy the stent outside the patient and the first knot loop was opened.The stent was reintroduced inside the patient and the stent was able to be deployed.However, the physician noticed that the stent was buckled and when the stent was pulled, it got coiled.The stent was removed with rat tooth forceps and the procedure was completed with a different device.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.
Additional Manufacturer Narrative
Block h6: device problem code 2976 captures the reportable event of stent material deformation.Block h10: an ultraflex tracheobronchial covered distal stent and delivery system were received for analysis.The stent was returned completely deployed.Visual inspection was performed and it was found that the shaft was kinked in several sections.The outer diameter and length of the stent were measured and found to be within specification.No other issues were noted to the stent and delivery system.The reported events of stent difficult to deploy and stent material deformation were not confirmed; the stent was received in good condition and without any damages.The kinks noted to the delivery system may have been a result of the use of excessive force applied to the device during use.The investigation concluded that the reported events and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated during the procedure, and the tight anatomy, limited the performance of the device and contributed to the difficulty deploying the stent and material deformation during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time 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.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be used to treat an approximately 2 cm malignant pulmonological obstruction during a bronchoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, resistance was felt during the attempt deployment.Force was applied in pulling the stent deployment suture, but the stent failed to open.The device was removed from the patient.Reportedly, the physician attempted to deploy the stent outside the patient and the first knot loop was opened.The stent was reintroduced inside the patient and the stent was able to be deployed.However, the physician noticed that the stent was buckled and when the stent was pulled, it got coiled.The stent was removed with rat tooth forceps and the procedure was completed with a different device.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.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10140080
• Report Number: 3005099803-2020-02164
• Device Sequence Number: 2420953
• Product Code: JCT
• UDI-Device Identifier: 08714729842446
• UDI-Public: 08714729842446
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: M00576640
• Device Catalogue Number: 7664
• Device Lot Number: 0023244262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 58