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

Model Number M00564910

Device Problems Break (1069); Human-Device Interface Problem (2949); Migration (4003)

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

Event Date 01/08/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted 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 covered distal release stent was implanted to release the external pressure caused by the malignant tumor in the longitudinal wall of the main trachea during a stent placement procedure performed on (b)(6) 2022.On (b)(6) 2022, post stent placement, it was noted that the stent migrated distally.The physician attempted to reposition the stent by grabbing the stent retention sutures; however, the stent sutures were damaged.The physician then grabbed the metal part of the stent and repositioned the stent back to its original position.The original stent remains implanted and the procedure was completed.In the physician's assessment, concomitant use of radiation therapy may have caused the tumor to shrink and the stent to migrate more easily.There were no patient complications reported due to this event.The patient's current condition was reported to be stable.

Event Description

It was reported to boston scientific corporation on january 11, 2022 that an ultraflex tracheobronchial covered distal release stent was implanted to release the external pressure caused by the malignant tumor in the longitudinal wall of the main trachea during a stent placement procedure performed on (b)(6) 2022.On (b)(6) 2022, post stent placement, it was noted that the stent migrated distally.The physician attempted to reposition the stent by grabbing the stent retention sutures; however, the stent sutures were damaged.The physician then grabbed the metal part of the stent and repositioned the stent back to its original position.The original stent remains implanted and the procedure was completed.In the physician's assessment, concomitant use of radiation therapy may have caused the tumor to shrink and the stent to migrate more easily.There were no patient complications reported due to this event.The patient's current condition was reported to be stable.**additional information received on february 01, 2022**.The ultraflex tracheobronchial stent was implanted to treat a 7cm malignant tumor in the longitudinal wall of the main trachea.The patient's anatomy was not tortuous and was not dilated prior to stent placement.The stent was repositioned to its original position with forceps.Furthermore, granulation tissue was noted on the proximal side of the stent so an additional stent will be placed at a later date.

Manufacturer Narrative

Blocks b5, d4 (lot number, expiration date), h4, h6 (device code) have been updated with additional information received on february 01, 2022.Block h6: medical device problem code a010402 captures the reportable event of stent migration.Medical device problem code a0401 captures the reportable event of stent suture break.Medical device problem code a22 captures the reportable event of stent overgrowth.Impact code f23 captures the additional intervention of stent repositioning.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the stent remains implanted 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.

• 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: 13440553
• MDR Text Key: 284968764
• Report Number: 3005099803-2022-00430
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2022
• Device Model Number: M00564910
• Device Catalogue Number: 6491
• Device Lot Number: 0026254612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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