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

Device Problems Unraveled Material (1664); Use of Device Problem (1670); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 stent had been implanted to treat tracheomalacia during a stent placement procedure performed approximately two years ago.According to the complainant, on (b)(6) 2020, computed tomography (ct) scan was taken and the stent was found kinked and looked frayed at the distal end, which partially obstructed the trachea.A bronchoscopy procedure was performed and the ultraflex tracheobronchial stent was removed piecemeal from the patient.A new stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: according to the complainant, the ultraflex tracheobronchial stent had been implanted to treat tracheomalacia.Per the ultraflex tracheobronchial stent system directions for use (dfu), the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Event Description

It was reported to boston scientific corporation on february 12, 2020 that an ultraflex tracheobronchial stent had been implanted to treat tracheomalacia during a stent placement procedure performed approximately two years ago.According to the complainant, on (b)(6) 2020, computed tomography (ct) scan was taken and the stent was found kinked and looked frayed at the distal end, which partially obstructed the trachea.A bronchoscopy procedure was performed and the ultraflex tracheobronchial stent was removed piecemeal from the patient.A new stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: according to the complainant, the ultraflex tracheobronchial stent had been implanted to treat tracheomalacia.Per the ultraflex tracheobronchial stent system directions for use (dfu), the stent is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Manufacturer Narrative

Block e1 (initial reporter's city, state, zipcode, phone number and email) has been updated with additional information received on march 12, 2020.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: problem code 1664 captures the reportable event of stent looked frayed at the distal end.Problem code 2976 captures the reportable event of stent kinked.Patient code 3191 captures the reported additional intervention to remove the stent.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; 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.

• 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: 9795304
• MDR Text Key: 189437286
• Report Number: 3005099803-2020-00742
• 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: 04/06/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention