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

Model Number M00564790

Device Problem Activation Failure (3270)

Patient Problem Hypoxia (1918)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

The initial reporter's address 1: (b)(6).(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 Description

It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant tracheostenosis during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed.After deployment, the delivery system was removed and a bronchoscope was used to observe the stent.Reportedly,the physician found the stent expansion was not obvious and the stent could not fully appose the airway stenosis.The bronchoscope was removed and reportedly, the patient sat up and felt the breath was not smooth.According to the physician, the patient's blood oxygen saturation decreased to 70%.The patient was given with oxygen and the stent was immediately removed.The procedure was completed with another ultraflex tracheobronchial stent.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the initial reporter's address 1: (b)(6).Block h6: patient code 1918 captures the reportable event of hypoxia.Problem code 3270 captures the reportable event of stent failed to expand.Block h10: investigation results an ultraflex tracheobronchial covered distal release stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received deployed and expanded.The green retention suture was found broken.The outer diameter (od) of the stent was measured and the proximal section was found to be smaller than the od specification.No other issues were noted with the stent and delivery system.The reported event of stent failure to expand was confirmed; although the stent was received deployed and visually appeared expanded, during dimensional inspection, the proximal end of the stent was found to be smaller than the od specification.The damage noted on the stent suture was likely due to an excessive force applied during the attempt stent removal.A labeling review was peformed, and from the information available, this device was used per directions for use (dfu) / product label.Additionally, hypoxia/ oxygen desaturation is noted within the dfu as potential adverse event associated with the used of this device.Thus, the report of hypoxia was likely a result of stent failure to expand during the procedure.Taking all available information into consideration, the investigation concluded that the reported events and the observed failure are most likely due to factors encountered during the procedure such as how the device was handled or manipulated, the interaction with the scope, the tortuosity of the lesion and/ or prolonged 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 (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant tracheostenosis during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was successfully deployed.After deployment, the delivery system was removed and a bronchoscope was used to observe the stent.Reportedly,the physician found the stent expansion was not obvious and the stent could not fully appose the airway stenosis.The bronchoscope was removed and reportedly, the patient sat up and felt the breath was not smooth.According to the physician, the patient's blood oxygen saturation decreased to 70%.The patient was given with oxygen and the stent was immediately removed.The procedure was completed with another ultraflex tracheobronchial stent.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 9848879
• MDR Text Key: 189597666
• Report Number: 3005099803-2020-00849
• 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: 05/13/2020

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: 06/28/2020
• Device Model Number: M00564790
• Device Catalogue Number: 6479
• Device Lot Number: 0022319127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 62