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

Model Number	M00576530
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Problem code captures the reportable event of stent failed to expand.Problem code captures the reportable event of stent positioning/ placement problem.Conclusion code is being used in lieu of an adequate conclusion code for device not returned.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplement mdr will be filed.
Event or Problem Description
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2018-60988 and 3005099803-2018-60989 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2018 that two ultraflex tracheobronchial covered distal release stents were to be used to treat a malignant stricture due to a tumor in the airway during a pulmonary stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent deployment suture was released, but the first ultraflex tracheobronchial stent (the subject of mfr.Report # 3005099803-2018-60988) would not expand.It was reported that the plastic lumen on the stent would not open and remained compressed against the catheter.Reportedly, the stent ended up deploying "too high up" and was not deployed in the proper location.The physician removed the stent with forceps.A second ultraflex tracheobronchial stent (the subject of this report) was used, but the same issue had occurred.The procedure was completed with another ultraflex tracheobronchial stent of different size.There were no patient complications reported.The patient's condition following the procedure was reported to be fine.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8005620
• Report Number: 3005099803-2018-60989
• Device Sequence Number: 18882688
• Product Code: JCT
• UDI-Device Identifier: 08714729842330
• UDI-Public: 08714729842330
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2020
• Device Model Number: M00576530
• Device Catalogue Number: 56598
• Device Lot Number: 0021882553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention