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

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pneumonia (2011); Respiratory Distress (2045); Stenosis (2263); No Code Available (3191)

Event Date 02/14/2013

Event Type  Injury  

Manufacturer Narrative

Age: the patients' ages ranged from 25 to 66 years old.Lot #, expiration date, manufacture date: the upns and lot numbers were not reported; therefore, the manufacture dates and expiration dates are unknown.Report source: literature source: gaissert, henning a., et al."complication of benign tracheobronchial strictures by self-expanding metal stents." the journal of thoracic and cardiovascular surgery 126.3 (2003): 744-747.Doi: https://doi.Org/10.1016/s0022-5223(03)00361-1.(b)(4).The devices have not been received for analysis; therefore a failure analysis of the complaint devices could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific corporation became aware of multiple events involving ultraflex tracheobronchial stents through the article "complication of benign tracheobronchial strictures by self-expanding metal stents" written by henning a.Gaissert, md, et al.According to the literature, the aim of the study was to examine and report the complications associated with the use of self-expanding metal stent to palliate benign strictures in 15 patients.Between 1997 and 2002, recurrent airway obstruction and extension of inflammatory strictures were observed after placement of ultraflex tracheobronchial stents (the subject of this report) and wallstents (the subject of manufacturer's report # 2134265-2019-07975).9 patients received ultraflex tracheobronchial stents; 3 were coated/covered and 6 were uncovered.The indications for the ultraflex tracheobronchial stents included postintubation tracheal stenosis (5), broncholith with complications from a flash fire in the trachea during a laser treatment (1), sarcoidosis and tracheomalacia (1), bronchomalacia (1) and wegener's granulomatosis (1).All patients underwent bronchoscopic examination under general anesthesia, which revealed stenosis or granulations at either end or growing through the interstices of the stents.Stents were completely or partially extracted in 13 of the 15 total patients.Stent extraction was attempted during endoscopy under general anesthesia unless ingrowth into the tracheal wall precluded safe removal.When endoscopic extraction proved impossible, open removal was achieved through a vertically enlarged tracheostomy.Nearly complete removal of the stent was preferred and sometimes required piecemeal extraction.The stent portion embedded in the membranous wall was left in place to avoid tracheoesophageal fistula.At presentation, all patients had symptoms of airway obstruction.All patients had dyspnea and 8 had stridor.Coated/covered stents were found covered with purulent debris and caused severe halitosis in 3 patients.Seven patients had high-grade circumferential strictures of 6-mm diameter or less.In the ultraflex patients, the location of strictures was above the stent in 5 patients, and both above and below the stent in 3 patients.Comparison with bronchoscopy notes before stenting found new strictures in adjacent airway segments in 11 patients.Among 9 patients with original injuries limited to the trachea, additional strictures were subglottic in 8, with new hoarseness in 4, and carinal in 1.In correspondence with boston scientific, the author reported that pressure on normal tracheal wall damages the part of the mucosa that is not strictured and extends the injury, and any self-expanding stent damages normal tracheal or bronchial wall.Five patients had clinical infection, and tracheal aspirates at bronchoscopy demonstrated pathologic organisms in 12 patients.In correspondence with boston scientific, the author reported that all stents without tracheostomy eventually end up being colonized with bacteria, and secretions are present to a varying extent.3 patients with ultraflex tracheobronchial stents had purulent tracheitis.These patients had the stent implanted for 1, 4, and 5 months.At 26 months post-placement of an ultraflex tracheobronchial uncovered stent, one patient had pneumonia due to a wire-related bronchoesophageal fistula.In this patient, oral intake was discontinued and nutrition was performed once the pneumonia resolved and the patient's condition allowed closure of the fistula.This patient underwent bronchial resection with closure of the esophageal fistula.The goal of intervention was a stable airway without progression of injury.Surgical reconstruction was deferred until the true extent of airway damage became apparent, even if temporary t-tube stenting was required.When the airway could not be reconstructed by resection, a silicone t-tube or ty-tube was inserted.4 of the patients with ultraflex stents had lesions that were judged resectable prior to stent placement.Of these 4 patients, 2 underwent laryngotracheal resection, with subsequent placement of a palliative t-tube in 1.The other 2 patients did not undergo resection.1 had a palliative t-tube placed and 1 had a palliative trach-tube placed.Of the other 5 ultraflex patients, 1 underwent bronchial resection with closure of their esophageal fistula, 3 were treated with t- or tracheostomy tubes, and 1 underwent evaluation only.According to the article, the ultraflex tracheobronchial stents were implanted to treat benign strictures; however, according to the dfu (directions for use) "the ultraflex tracheobronchial stent system is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.".

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 8795715
• MDR Text Key: 151206460
• Report Number: 3005099803-2019-03641
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention