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

Model Number M00564860

Device Problem Activation Failure (3270)

Patient Problem Hypoxia (1918)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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) 2019 that an ultraflex tracheobronchial stent was to be used to treat a malignant stricture in the airway in the right main trachea during an airway constriction and dilation performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed; however, the stent failed to expand.The stent blocked part of the trachea which caused the patient's oxygen concentration to drop to 68-74.The stent was removed with forceps and another ultraflex tracheobronchial stent was implanted to complete the procedure.Reportedly, the patient received the oxygen up-taking continually for the hypoxia.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 july 25, 2019 that an ultraflex tracheobronchial stent was to be used to treat a malignant stricture in the airway in the right main trachea during an airway constriction and dilation performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed; however, the stent failed to expand.The stent blocked part of the trachea which caused the patient's oxygen concentration to drop to 68-74.The stent was removed with forceps and another ultraflex tracheobronchial stent was implanted to complete the procedure.Reportedly, the patient received the oxygen up-taking continually for the hypoxia.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Problem code 3270 captures the reportable event of stent failed to expand.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 deployed and expanded.The stent was measured to be within specification.No other issues with the stent were noted.The reported event of stent failure to expand could not be confirmed as the stent was received deployed and expanded.Based on all available information, the investigation concluded that the most probable cause classification of the reported hypoxia is known inherent risk of device, which indicates that the adverse event is known and documented in the labelling.The investigation concluded that the reported failure to expand was likely due to anatomical or procedural factors such as characteristics of the lesion, handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, "oxygen desaturation related to sedation or procedural instrumentation infection" is noted within the dfu as a potential adverse events associated with the use of this device.

• 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: 8905658
• MDR Text Key: 154715888
• Report Number: 3005099803-2019-04145
• 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: 10/01/2019

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: 09/08/2019
• Device Model Number: M00564860
• Device Catalogue Number: 6486
• Device Lot Number: 0021108479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 48