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

Model Number M00564870

Device Problem Activation Failure (3270)

Patient Problems Dyspnea (1816); Pneumothorax (2012); Heart Failure (2206)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on december 09, 2019 that an ultraflex tracheobronchial stent was to be used to treat a stricture in the main airway carina during tracheal stent implantation performed on (b)(6) 2019.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted that the stent was slow to fully expand.Five minutes post stent implantation, the patient sat up and experienced dyspnea leading to heart failure.The physician then decided to remove the stent and the procedure was completed with another ultraflex tracheobronchial stent.The patient's condition at the conclusion of the procedure was reported to be stable but the physician also noted that the patient had pneumothorax.In the physician's assessment, the heart failure, dyspnea and pneumothorax were related to the stent.Reportedly, according to the physician the heart failure and dyspnea were caused by the stent failing to fully expand in the trachea.According to the physician, the pneumothorax was caused by the heart failure.The endoscopic stent removal was the only intervention reported to address the heart failure, dyspnea and pneumothorax.

Manufacturer Narrative

Block e1: initial report's address 1: (b)(6).Block h6: patient code 2206 captures the reportable event of patient experienced heart failure.Patient code 1816 captures the reportable event of patient experienced dyspnea.Patient code 2012 captures the reportable event of patient had pneumothorax.Problem code 3270 captures the reportable event of stent failed to expand.Block h10: 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 received deployed and expanded.The stent was measured to be within specifications.No damages were noted to both stent and retention suture.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/ product label.Furthermore, heart failure, dyspnea and pneumothorax are noted within the dfu as potential adverse events associated with the use of the device.The reported event of stent failure to expand cannot be confirmed given that the stent was received fully expanded.Also, no visible damage noted on the stent.Taking all available information into consideration, the investigation concluded that the reported event of stent failure to expand may be related to procedural factors such as handling of the device, the technique used by the user and normal procedural difficulties encountered the procedure, which limited the performance of the device.Therefore, the most probable cause is 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.

Event Description

It was reported to boston scientific corporation on december 09, 2019 that an ultraflex tracheobronchial stent was to be used to treat a stricture in the main airway carina during tracheal stent implantation performed on (b)(6) 2019.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted that the stent was slow to fully expand.Five minutes post stent implantation, the patient sat up and experienced dyspnea leading to heart failure.The physician then decided to remove the stent and the procedure was completed with another ultraflex tracheobronchial stent.The patient's condition at the conclusion of the procedure was reported to be stable but the physician also noted that the patient had pneumothorax.In the physician's assessment, the heart failure, dyspnea and pneumothorax were related to the stent.Reportedly, according to the physician the heart failure and dyspnea were caused by the stent failing to fully expand in the trachea.According to the physician, the pneumothorax was caused by the heart failure.The endoscopic stent removal was the only intervention reported to address the heart failure, dyspnea and pneumothorax.

• 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: 9520044
• MDR Text Key: 172902288
• Report Number: 3005099803-2019-06295
• 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: 02/27/2020

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: 01/23/2021
• Device Model Number: M00564870
• Device Catalogue Number: 6487
• Device Lot Number: 0023237942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65