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

Model Number M00564760

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a problem 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) 2022 that an ultraflex tracheobronchial distal release stent was to be implanted to treat a lung cancer during a bronchoscopy with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent did not fully expand at the middle section.The stent was removed from the patient and was found broken.The procedure was not completed because another stent was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent did not fully expand and was broken.

Manufacturer Narrative

Block b5 has been updated with the additional information received on april 26, 2022.Block h6: medical device problem code a150101 captures the reportable event of stent failure to expand.Medical device problem code a0401 captures the reportable event of stent break.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a problem 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 march 30, 2022 that an ultraflex tracheobronchial distal release stent was to be implanted to treat a lung cancer during a bronchoscopy with stent placement procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent did not fully expand at the middle section.The stent was removed from the patient and was found broken.The procedure was not completed because another stent was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent did not fully expand and was broken.Additional information received on april 26, 2022 according to the complainant, the stent was removed from the patient with a 1.8 rescue rat tooth forceps.

Manufacturer Narrative

Blocks b5 and h6 (device code) have been updated with the additional information received on (b)(6) 2022 and (b)(6), 2022.Block h6: medical device problem code a150101 captures the reportable event of stent failure to expand.Block h10: a fully deployed ultraflex tracheobronchial stent was received for analysis; the delivery system was not returned.The stent was returned fully expanded.Visual examination of the returned device did not find any damages to the stent.However, a media inspection was performed of a photo provided by the customer and it was observed that the stent was not fully expanded.No other damages were noted to the photo.The reported event of stent failure to expand was likely due to anatomical structure not correctly dilated during the procedure.However, during visual inspection, the reported event of stent failure to expand was not confirmed as the ultraflex tracheobronchial stent was received fully expanded.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.

Event Description

It was reported to boston scientific corporation on (b)(6), 2022 that an ultraflex tracheobronchial distal release stent was to be implanted to treat a lung cancer during a bronchoscopy with stent placement procedure performed on (b)(6), 2022.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent did not fully expand at the middle section.The stent was removed from the patient and was found broken.The procedure was not completed because another stent was unavailable.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent did not fully expand and was broken.***additional information received on (b)(6), 2022*** according to the complainant, the stent was removed from the patient with a 1.8 rescue rat tooth forceps.***additional information received on (b)(6), 2022 and (b)(6), 2022*** the complainant reported that the ultraflex tracheobronchial stent was not broken.During the sterilization process, the ultraflex tracheobronchial stent was exposed to a high temperature environment causing the stent to expand.The photo previously submitted was taken before sterilization.

• 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: 14172619
• MDR Text Key: 289897451
• Report Number: 3005099803-2022-02063
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0025947434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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: 54 YR
• Patient Sex: Male