Ultraflex TracheobronchialRecalls & reported problems across all models

We found 25 models of Ultraflex Tracheobronchial by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2016 and Jul 27, 2026 — classified as 1 death, 36 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ultraflex Tracheobronchial problems

Ultraflex Tracheobronchial models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ultraflex™ Tracheobronchial M00576560

  Prosthesis, tracheal, expandable
  9 reports
• Ultraflex™ Tracheobronchial M00576530

  Prosthesis, tracheal, expandable
  6 reports
• Ultraflex™ Tracheobronchial M00576550

  Prosthesis, tracheal, expandable
  6 reports
• Ultraflex™ Tracheobronchial M00576570

  Prosthesis, tracheal, expandable
  4 reports
• Ultraflex™ Tracheobronchial M00576580

  Prosthesis, tracheal, expandable
  4 reports
• Ultraflex™ Tracheobronchial M00576410

  Prosthesis, tracheal, expandable
  3 reports
• Ultraflex™ Tracheobronchial M00576430

  Prosthesis, tracheal, expandable
  3 reports
• Ultraflex™ Tracheobronchial M00576640

  Prosthesis, tracheal, expandable
  3 reports
• Ultraflex™ Tracheobronchial M00576650

  Prosthesis, tracheal, expandable
  3 reports
• Ultraflex™ Tracheobronchial M00576670

  Prosthesis, tracheal, expandable
  3 reports
• Ultraflex™ Tracheobronchial M00576310

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576320

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576480

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576490

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576540

  Prosthesis, tracheal, expandable
  1 death2 reports
• Ultraflex™ Tracheobronchial M00576610

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576620

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576690

  Prosthesis, tracheal, expandable
  2 reports
• Ultraflex™ Tracheobronchial M00576300

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576330

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576380

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576440

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576450

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576470

  Prosthesis, tracheal, expandable
  1 report
• Ultraflex™ Tracheobronchial M00576590

  Prosthesis, tracheal, expandable
  1 report

Recent Ultraflex Tracheobronchial adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from January 2023 to December 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date: (b)(6) 2017. Patient Discharge Date: (b)(6) 2017. Adverse Event including Hemoptysis. Twenty-two days after discharge, the patient passed away.Note: IMDFR code F08 (Hospitalization or Prolonged Hospitalization), B1 (Adverse Event), and B2 (Hospitalization, Initial or Prolonged, dea

  Patient problems: Hemoptysis

  MAUDE report 50002918 ↗
• InjuryJul 27, 2026Migration

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from (b)(6) 2023 to (b)(6) 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date: (b)(6)2020. Patient Discharge Date: (b)(6) 2020. Displacement of device was observed. The patient underwent an endoscopic removal of an airway device and endoscopic inspection of the trachea and bronchi, and an Ultraflex Tracheobronchial Stent was subsequently placed.Note: IMDFR code

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002917 ↗
• InjuryJul 27, 2026Migration

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from (b)(6)2023 to(b)(6)2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date:(b)(6)2022. Patient Discharge Date: (b)(6) 2023. Displacement of device was observed. The patient underwent endoscopic removal of an intraluminal device from the trachea and a change of the endotracheal tube. The patient subsequently underwent an endoscopic removal of an intraluminal devi

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002890 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from January 2023 to December 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device.The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database.Patient Admission Date: April 21, 2022. Patient Discharge Date: August 31, 2022. Adverse Event including Hemoptysis. The patient underwent endoscopic removal of an intraluminal device from the tracheobronchial tree, followed by endoscopic repair of the right main bronchus and an Ultraflex Tracheobronchial

  Patient problems: Hemoptysis

  MAUDE report 50002889 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Boston Scientific Corporation performed a retrospective data analysis on the Ultraflex Tracheobronchial Stent System using the PINC AI Healthcare Database. Patients were identified through records associated with use of the Ultraflex Tracheobronchial Stent System. The Date Review Period ranges from January 2023 to December 2025. These analyses are being performed as a specific Post Market Clinical Follow up (PMCF) activity to assess the safety and performance of the subject device. The PINC AI Healthcare Database data is de-identified before being transmitted to Boston Scientific; thus, there are significant limitations to Boston Scientific's ability to correlate the data to information previously reported to Boston Scientific. Additionally, Event Date, Event Outcome, and Initial Reporter are not provided in the de-identified data due to the terms of the PINC AI Healthcare Database. Patient Admission Date: June 26, 2018. Patient Discharge Date: (b)(6) 2018. Adverse Event including Hemoptysis. The patient underwent an endoscopic insertion of an endobronchial valve into the right lower lobe bronchus. The patient also underwent removal of an intraluminal device from the trachea via an

  Patient problems: Hemoptysis

  MAUDE report 50002764 ↗
• InjuryJun 4, 2026Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS ATTEMPTED TO BE IMPLANTED TO THE LUNGS TO TREAT A STRICTURE CAUSED BY CANCER DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS. DURING THE PROCEDURE, WHEN THE SCOPE WAS RETRACTED, THE PHYSICIAN FELT RESISTANCE. UPON INSPECTION THROUGH THE SCOPE, IT WAS OBSERVED THAT THE STENT WAS CAUGHT ON THE ENDOTRACHEAL TUBE. REPORTEDLY, THE STENT WAS DIFFICULT TO BE REMOVED BUT IT WAS EVENTUALLY RETRIEVED BY USING FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE ARE NO PATIENT COMPLICATIONS REPORTED AS RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399410 ↗
• InjuryDec 2, 2025Use of Device Problem; Material Deformation; Positioning Problem; Activation Failure; Use of Device Problem; Material Deformation; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE MAIN BRONCHIAL TO TREAT A NARROWING IN THE AIRWAY FOR MORE LUNG VOLUME DURING A TRACHEOBRONCHIAL STENT PLACEMENT PERFORMED ON (B)(6) 2025. THE PATIENT WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE RELEASED FROM THE DELIVERY SYSTEM. HOWEVER, THE STENT DID NOT LOOK RIGHT AND WAS STILL SMASHED DOWN, AND THE STENT DID NOT EXPAND OFF THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO PULL THE STENT AND PLACED ANOTHER TRACHEOBRONCHIAL STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696074 ↗
• MalfunctionJun 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED DURING AN UNSPECIFIED PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE DEVICE WAS FOUND DEFECTIVE BEFORE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTED: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS, WHICH REVEALED THAT THE TIP WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187147 ↗
• MalfunctionOct 16, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE AIRWAY DURING A BRONCHOSCOPY WITH STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DEPLOYMENT SUTURE GOT STUCK AND THE STENT COULD NOT BE FULLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467454 ↗
• InjuryApr 1, 2024Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01392 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENTS WERE TO BE IMPLANTED IN THE LOWER LEFT LOBE OF THE LUNGS TO TREAT BRONCHIAL STRICTURES SECONDARY TO LUNG CANCER DURING A BRONCHIAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT), THE STENT DEPLOYMENT SUTURE GOT STUCK CAUSING THE SHAFT TO BEND. THE STENT WAS ABLE TO FULLY DEPLOY; HOWEVER, IT MOVED AWAY FROM THE INTENDED POSITION. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT NUMBER) WAS OPENED AND THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS EVENTUALLY CANCELED AND RESCHEDULED FOR LATER THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014501 ↗
• InjuryApr 1, 2024Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-01391 AND 3005099803-2024-01392 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL STENTS WERE TO BE IMPLANTED IN THE LOWER LEFT LOBE OF THE LUNGS TO TREAT BRONCHIAL STRICTURES SECONDARY TO LUNG CANCER DURING A BRONCHIAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT NUMBER 3005099803-2024-01391), THE STENT DEPLOYMENT SUTURE GOT STUCK CAUSING THE SHAFT TO BEND. THE STENT WAS ABLE TO FULLY DEPLOY; HOWEVER, IT MOVED AWAY FROM THE INTENDED POSITION. A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS OPENED AND THE SAME PROBLEM OCCURRED. THE STENTS WERE REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS EVENTUALLY CANCELED AND RESCHEDULED FOR LATER THE SAME DAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014497 ↗
• MalfunctionMar 5, 2024Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE STENT WAS TO BE IMPLANTED IN THE AIRWAY FOR PALLIATIVE TREATMENT DURING A TRACHEOBRONCHIAL (TB) STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY CORRECTLY. THE STENT WAS REMOVED FROM THE PATIENT, AND A DIFFERENT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A REVIEW OF THE PROVIDED PHOTO OF THE COMPLAINT DEVICE REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, THE SHAFT APPEARED KINKED, AND THE TIP WAS NOTED TO BE DETACHED. ***ADDITIONAL INFORMATION RECEIVED ON MARCH 19, 2024*** IN THE PHYSICIAN'S ASSESSMENT, THE TIP OF THE DEVICE WAS DETACHED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841667 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-00164 AND 3005099803-2024-00163 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE INTERMEDIUS BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF THIS REPORT) WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE STENT OUTSIDE AND WAS ABLE TO UNRAVEL THE FIRST TWO SUTURES. THE STENT WAS RELOADED, AND ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-00163) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT "THE STENT WAS REMOVED, AND THE FIRST TWO SUTURES WERE UNRAVELED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636294 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2024-00164 AND 3005099803-2024-00163 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED IN THE INTERMEDIUS BRONCHUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2024-00164) WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE STENT OUTSIDE AND WAS ABLE TO UNRAVEL THE FIRST TWO SUTURES. THE STENT WAS RELOADED, AND ANOTHER ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE STENT STILL DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT "THE STENT WAS REMOVED, AND THE FIRST TWO SUTURES WERE UNRAVELED O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631266 ↗
• MalfunctionFeb 2, 2024Use of Device Problem; Activation, Positioning or Separation Problem; Use of Device Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED IN THE BRONCHUS INTERMEDIUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY PULLING THE SUTURE WITH EXCESSIVE FORCE, BUT THE STENT COULD NOT BE DEPLOYED. THE STENT WAS THEN REMOVED FROM THE PATIENT, AND THE FIRST TWO SUTURES WERE MANUALLY UNRAVELED. THE PARTIALLY DEPLOYED STENT WAS PUT BACK INTO THE PATIENT TO ATTEMPT FULL DEPLOYMENT, BUT IT COULD STILL NOT BE DEPLOYED USING EXCESSIVE FORCE. A NON-BOSTON SCIENTIFIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE FIRST TWO SUTURES WERE MANUALLY UNRAVELED AND THE STENT WAS PUT BACK INSIDE THE PATIENT TO ATTEMPT FULL DEPLOYMENT. PER THE INSTRUCTIONS FOR USE (IFU), "WARNING: DO NOT ATTEMPT TO RELOAD A DEPLOYED OR PARTIALLY DEPLOYED STENT." THE USER DID NOT FOLLOW THE STEPS OF THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631075 ↗

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