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

Model Number M00564880

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter's address 1:(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 september 15, 2021 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat an airway stenosis with external atmospheric pressure during a procedure performed on (b)(6) 2021.During the procedure, the stent was successfully deployed.However, the physician noticed that the stent was a bit too long and it reached the airway.Reportedly, the patient felt uncomfortable and two days post stent placement, the stent was removed from the patient.Another ultraflex tracheobronchial stent was implanted and the procedure was completed.The patient's condition following the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation on september 15, 2021 that an ultraflex tracheobronchial covered distal release stent was implanted to treat an airway stenosis with external atmospheric pressure during a procedure performed on (b)(6) 2021.During the procedure, the stent was successfully deployed.However, the physician noticed that the stent was a bit too long and it reached the airway.Reportedly, the patient felt uncomfortable and two days post stent placement, the stent was removed from the patient.Another ultraflex tracheobronchial stent was implanted and the procedure was completed.The patient's condition following the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information was received on october 19, 2021.He stent was implanted during a flexible bronchoscope procedure.The stenosis being treated was malignant.It was reported that the stent was the labeled length; however, the stent was too long for the patient's anatomy.

Manufacturer Narrative

Blocks b5 and h6 (device code, impact code) have been updated with additional information received on october 19, 2021.The reported malfunction of stent size being the incorrect length was rescinded.Block h6: medical device problem code a0203 captures the reportable event of stent size incorrect.Block h10: an ultraflex tracheobronchial stent and delivery system were returned for analysis.The stent was retuned fully deployed.The stent was not fully expanded; however, during functional inspection the stent was immersed in warm water and the stent fully expanded.No other issues with the device were noted.The reported event was confirmed; no malfunction of the device was reported and no issues of the device were noted during device evaluation.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: blocks e1 (initial reporter title, first and last name, facility name, address 1, address 2, initial reporter city, phone, email, and fax) have been corrected.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that an ultraflex tracheobronchial covered distal release stent was implanted to treat an airway stenosis with external atmospheric pressure during a procedure performed on (b)(6) 2021.During the procedure, the stent was successfully deployed.However, the physician noticed that the stent was a bit too long and it reached the airway.Reportedly, the patient felt uncomfortable and two days post stent placement, the stent was removed from the patient.Another ultraflex tracheobronchial stent was implanted and the procedure was completed.The patient's condition following the procedure was reported to be stable.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information was received on october 19, 2021 the stent was implanted during a flexible bronchoscope procedure.The stenosis being treated was malignant.It was reported that the stent was the labeled length; however, the stent was too long for the patient's anatomy.

Manufacturer Narrative

Blocks b5 and h6 (device code, impact code) have been updated with additional information received on october 19, 2021.The reported malfunction of stent size being the incorrect length was rescinded.Block e1: initial reporter's address 1: (b)(6).Block h6: medical device problem code a0203 captures the reportable event of stent size incorrect.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12614966
• MDR Text Key: 275882394
• Report Number: 3005099803-2021-05244
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2021
• Device Model Number: M00564880
• Device Catalogue Number: 6488
• Device Lot Number: 0023762670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 64 KG