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

Model Number	M00576620
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a 3 cm malignant stricture in the trachea during a tracheal stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed; however, immediately after deployment, the stent moved into an incorrect position.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a 3 cm malignant stricture in the trachea during a tracheal stent placement procedure performed on (b)(6), 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed; however, immediately after deployment, the stent moved into an incorrect position.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchal stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's phone number: (b)(6) block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Block h10: an ultraflex tracheobronchial covered distal stent and delivery system were received for analysis and no damages were noted with the returned device.The reported event of stent positioning issue was not confirmed as this failure occurred during the procedure and it is not possible to replicate the failure in the laboratory of analysis.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/ product label.Additionally, stent misplacement is noted within the ifu as a known potential adverse event related to the use of the device.A review and analysis of all available information indicated the reported event of stent positioning issue is known and documented in the labeling.Therefore, the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 11138965
• Report Number: 3005099803-2020-06648
• Device Sequence Number: 631878
• Product Code: JCT
• UDI-Device Identifier: 08714729842422
• UDI-Public: 08714729842422
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

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: 03/31/2022
• Device Model Number: M00576620
• Device Catalogue Number: 7662
• Device Lot Number: 0025427233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/23/2021
• 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