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

Model Number M00564840

Device Problem Activation Failure (3270)

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

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

(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 mdr 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 implanted above the main airway carina during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient was in terrible condition prior to the scheduled procedure.According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted the stent was slow to fully expand.Reportedly, a minute after stent implantation the patient sat up and experienced difficulty breathing leading to cardiac failure and a pneumothorax.The stent was removed using forceps and another ultraflex tracheobronchial stent was used to complete the procedure.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.Reportedly, in the physician's assessment, the cardiac failure was caused by the stent failure to expand and the pneumothorax was caused by hyperventilation due to cardiac failure.Reportedly, the patient did not go into cardiac arrest and did not have a syncopal or vaso-vagal episode.Deploying the second stent was the only intervention reported to address the cardiac failure, difficulty breathing and pneumothorax.

Manufacturer Narrative

Block h6: problem code 3270 captures the reportable event of stent slow to fully expand.Patient code 2206 captures the reportable event of heart failure.Patient code 1816 captures the reportable event of dyspnea.Patient code 2012 captures the reportable event of pneumothorax.Block h10: an ultraflex tracheobronchial covered stent was received for analysis; the delivery system was not returned.The stent was received completely deployed.Visual examination of the returned device found the stent cover was torn.The loops of the stent were found bent.The outer diameter (od) of the stent was measured and was found to be within specification.No other issues were noted to the stent.The reported event of stent failure to expand was not confirmed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, the anatomy of the patient, the radial force of the stent and/or some issue with the retention suture during the procedure, limited the performance of the device and contributed to the stent failure to expand and the observed damage on the stent cover.Additionally, the loops of the stent were bent; however, there is not sufficient information about what could be the cause for this failure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the 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, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / product label.Additionally, pneumothorax and dyspnea are noted within the dfu as known potential adverse events associated with the use of this device.

Event Description

It was reported to boston scientific corporation on june 24, 2020 that an ultraflex tracheobronchial covered distal release stent was implanted above the main airway carina during a tracheal stent implantation procedure performed on (b)(6) 2020.Reportedly, the patient was in terrible condition prior to the scheduled procedure.According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted the stent was slow to fully expand.Reportedly, a minute after stent implantation the patient sat up and experienced difficulty breathing leading to cardiac failure and a pneumothorax.The stent was removed using forceps and another ultraflex tracheobronchial stent was used to complete the procedure.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.Reportedly, in the physician's assessment, the cardiac failure was caused by the stent failure to expand and the pneumothorax was caused by hyperventilation due to cardiac failure.Reportedly, the patient did not go into cardiac arrest and did not have a syncopal or vaso-vagal episode.Deploying the second stent was the only intervention reported to address the cardiac failure, difficulty breathing and pneumothorax.Additional information received on july 31, 2020.Reportedly, the reported heart/cardiac failure was not a pre-existing condition that the patient was diagnosed with prior to the procedure.

Manufacturer Narrative

Blocks b5 has been updated with the additional information received on (b)(6), 2020.Block h6: problem code 3270 captures the reportable event of stent slow to fully expand.Patient code 2206 captures the reportable event of heart failure.Patient code 1816 captures the reportable event of dyspnea.Patient code 2012 captures the reportable event of pneumothorax.Block h10: 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 mdr 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 implanted above the main airway carina during a tracheal stent implantation procedure performed on (b)(6), 2020.Reportedly, the patient was in terrible condition prior to the scheduled procedure.According to the complainant, after the stent deployed, the physician checked the stent using the bronchoscope and noted the stent was slow to fully expand.Reportedly, a minute after stent implantation the patient sat up and experienced difficulty breathing leading to cardiac failure and a pneumothorax.The stent was removed using forceps and another ultraflex tracheobronchial stent was used to complete the procedure.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.Reportedly, in the physician's assessment, the cardiac failure was caused by the stent failure to expand and the pneumothorax was caused by hyperventilation due to cardiac failure.Reportedly, the patient did not go into cardiac arrest and did not have a syncopal or vaso-vagal episode.Deploying the second stent was the only intervention reported to address the cardiac failure, difficulty breathing and pneumothorax.***additional information received on (b)(6), 2020*** reportedly, the reported heart/cardiac failure was not a pre-existing condition that the patient was diagnosed with prior to the procedure.

• 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: 10270255
• MDR Text Key: 198700144
• Report Number: 3005099803-2020-02750
• 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,Followup
• Report Date: 09/22/2020

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: 10/01/2020
• Device Model Number: M00564840
• Device Catalogue Number: 6484
• Device Lot Number: 0022734118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/31/2020; 09/01/2020
• Supplement Dates FDA Received: 08/21/2020; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 65