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BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE
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Back to Search Results |
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| Model Number M00576380 |
| Device Problems
Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Human-Device Interface Problem (2949); Positioning Problem (3009); Migration (4003)
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| Patient Problems
Death (1802); Dyspnea (1816); Hemoptysis (1887); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Respiratory Distress (2045); Disability (2371); Respiratory Tract Infection (2420); No Code Available (3191)
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| Event Date 10/03/2013 |
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Event Type
Death
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2019 as no specific event date was reported.The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device remains implanted 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.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial uncovered stent had been implanted to treat a benign stricture due to an allergic reaction to medication in 2009 or 2010.It was reported that the stent broke inside the patient on an unknown date.Reportedly, the patient has had over eighteen surgeries to try to remove the stent and has been transferred to multiple different hospitals; from (b)(6) (where the stent was initially implanted) to (b)(6)then to (b)(6).Reportedly, the patient is now on a ventilator and disability due to damages related to the stent being left in place.Note: according to the complainant, the ultraflex tracheobronchial stent was placed for an allergic reaction.However, per ultraflex tracheobronchial stent system directions for use, the stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial uncovered stent had been implanted to treat a benign stricture due to an allergic reaction to medication in 2009 or 2010.It was reported that the stent broke inside the patient on an unknown date.Reportedly, the patient has had over eighteen surgeries to try to remove the stent and has been transferred to multiple different hospitals; from memphis (where the stent was initially implanted) to (b)(6) then to (b)(6).Reportedly, the patient is now on a ventilator and disability due to damages related to the stent being left in place.Note: according to the complainant, the ultraflex tracheobronchial stent was placed for an allergic reaction.However, per ultraflex tracheobronchial stent system directions for use, the stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.Additional information noted on june 19, 2019: according to medical records, in december 2011, prior to placement of the ultraflex stent, the patient received hydralazine and developed anaphylaxis and upper airway swelling, requiring emergent tracheotomy.After eventual decannulation of the tracheostomy, a tracheal stenosis developed at the tracheostomy site.The ultraflex tracheobronchial uncovered stent was implanted on (b)(6) 2013, to treat this stricture.During the placement procedure, the stent was deployed at the level of the stenosis and forceps were used to move the stent up 4-5 mm so that there was complete coverage of the stenosis.According to the physician, the patient tolerated the procedure well.On an unknown date post stent placement, the patient was diagnosed with a tracheal stenosis.On (b)(6) 2013, a bronchoscopy was performed to assess the extent of the stenosis.Reportedly, the patient was experiencing shortness of breath and wheezing at this time.The bronchoscopy noted mild narrowing/mild compromise at the proximal aspect of the ultraflex stent.The stent lumen and distal trachea were free of obstruction.The patient tolerated the procedure well without complication.A microlaryngoscopy with laser and bronchoscopy was planned for (b)(6) 2013.The results of this procedure are unknown.On (b)(6) 2013, the patient underwent a tracheoscopy with tracheal dilatation.Reportedly, the patient was experiencing worsening dyspnea, and a core needle evaluation revealed narrowing at the proximal limb of the tracheal stent.The dilatation was uneventful, and the airway appeared to be improved.Examination revealed granulation tissue with a moderate amount of stenosis above the level of the tracheal stent.There were no abnormalities at the distal end of the stent.Approximately 30% narrowing was appreciated in the superior aspect.The patient appeared to tolerate the procedure well without complications.The patient underwent a bronchoscopy with dilatation and granulation tissue removal on (b)(6) 2013.On (b)(6) 2013, the patient was admitted to the hospital from the er due to coughing up blood.This stopped the next morning.On (b)(6) 2013, the patient complained of shortness of breath, thick mucous and dysphagia and did not feel that the prior dilatation had helped with their breathing.Reportedly, the patient's dysphagia resolved after balloon dilation on (b)(6) 2014.At this time, a computed tomography scan (ct) was done.On (b)(6)2014, it was noted that a review of history and imaging suggested that the ultraflex stent had migrated lower in the trachea and was not addressing the area of stenosis.The stenosis was 50% with tracheal diameter a little less than 1 cm at the worst point and 2cm or so below the cords.On (b)(6) 2014, a rigid bronchoscopy was performed and the stent was unable to be removed.According to the physician, the post tracheotomy stenosis was not being treated by the stent.The narrowing was noted to be mild.On (b)(6) 2014, it was reported that the patient's condition was unchanged, still with shortness of breath and a cough productive of yellow sputum.It was also noted that the patient had bad breath and had undergone frequent rounds of antibiotics.The patient underwent a rigid open tube bronchoscopy for stent revision and airway granulation/stenosis destruction with electrocautery.Intubation was difficult.Inspection with rigid tracheoscope showed tracheostomy site stenosis of 25%, with the lumen estimated to be 14mm.The proximal 1/3 of the stent was incorporated into the wall of the trachea, and some granulation tissue was noted distally.A cautery knife was used to remove some of the stenotic scar on the proximal edge of the stent and stent forceps were used to test how free the stent was.It was not free at all.Blunt tip cautery was used to treat the granulation on the distal end of the stent and the area of stenosis at the tracheostomy site was dilated to 18mm.The were no patient complications noted and the patient was stable at the conclusion of this procedure.Post procedure, it was noted that the patient did not have cp, wheezing or stridor.The patient was admitted after this procedure due to lack of transportation and was discharged on (b)(6) 2014.A bronchoscopy with balloon dilation was performed no may 08, 2014 and it was noted that there was no flow-limiting stenosis.On (b)(6) 2016, the patient reported that the shortness of breath had gotten a bit worse over the last six months.The patient reported having a bronchoscopy (date of procedure unknown) and that the orifice was much smaller.The patient was coughing up a moderate amount of greenish sputum, and had no fever, chills, nausea, vomiting or abdominal pain.A physical exam revealed no stridor or wheeze present over the lungs and no stridor present over the site of tracheostomy.A bronschoscopy with dilation was performed on (b)(6) 2016.On (b)(6) 2016, a direct laryngoscopy and flexible bronchoscopy with removal of mesh/airway foreign body was performed.On (b)(6) 2016, a bronchoscopy with foreign body removal and complex tracheostomy stoma revision was performed.According to the physician, removal of the ultraflex stent is a delicate process that can only be done when the stent presents itself.Additional surgeries to help correct the tracheal stenosis were performed on the following dates: (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017, (b)(6) 2017 (b)(6) 2018.A flexible bronchoscopy was performed on (b)(6) 2017.On (b)(6) 2017, the patient was seen for a cough, occasional coughing up blood, wheezing, and to discuss the stent.On (b)(6) 2018, the patient was seen for tracheostomy care and reported chronic pain, which the patient felt was related to the stent.A physical exam noted the patient was breathing well with no stridor, and no dyspnea on exertion (doe), retractions or air hunger.A fiberoptic endoscopy of the larynx, subglottis, and trachea was performed via the nare.Examination of the trachea noted that the prosthesis was well-seated, however wire mesh was visible distal to tracheostomy.The distal trachea/carina was patent with moderate dynamic collapse (tracheobronchomalacia) evident on cough.With the trach retracted, some granulation tissue and exposed wire of the stent was evident.There was no active bleeding, no mucopurulence, and no significant mucosal breakdown on either anterior or posterior tracheal walls.Examination of the subglottis noted that there was mild subglottic/proximal tracheal collapse above the current stomal site.The procedure was tolerated well without complication.There was no evidence of tracheoesophageal fistula nor tracheoinnominate fistula and there was no clinical evidence of active airway obstruction or active infection at the time of this exam.A ct of the neck was performed on (b)(6) 2018 and noted long segment loss of tracheal superstructure with integration of the ultraflex stent into the distal cervical and thoracic trachea.It was also noted that the tracheostomy tube entered the trachea through the ultraflex stent.An exam on (b)(6) 2018, noted that the patient was positive for cough and shortness of breath.It was also noted that the patient was seeing a physician who was, at intervals, removing pieces of the stent and that the patient had a recent admission with bleeding (bloody trach secretions).In the physician's opinion, the bloody trach secretions were likely due to the use of anticoagulants in the setting of exposed portions of the wire stent.The patient was admitted to the hospital from the emergency department on (b)(6) 2018.The patient was discharged on that date.On (b)(6) 2018, the patient reported that the episodes of bloody trach secretion began to increase as their anticoagulant prescription was modified.The patient reported no dyspnea, dysphagia, stridor, or any other complaints.A physical exam noted no bloody secretions from the trach apparent externally and no peristomal granulation tissue.The patient exhibited normal effort on humidified trach collar, equal chest rise, and no stridor or stertor.A fiberoptic endoscopy was performed and noted no active bleeding inside the airway and no mucus plugging.Previously visualized granulation tissue in the airway related to the ultraflex stent was significantly reduced.A flexible nasopharyngoscopy noted an ultraflex stent wire just distal to the tip of the tracheostomy tube, with some exposed free wire and surrounding granulation tissue.The area was noted to be irritated with no active bleeding.The procedure was tolerated well without complication.On an unknown date, the patient saw a thoracic surgeon, who performed a rigid bronchoscopy, esophagoscopy, and open neck exploration.There appeared to be a stomal stenosis due to cartilage collapse, and the esophagus was normal without evidence of constriction or tracheoesophageal fistula.During this procedure, there was an attempt to remove the stent through an open neck incision; however, the stent could not be removed under direct open visualization due to tight integration into the airway mucosa.The procedure was completed by placing a 14 mm t-tube (with the proximal limb cut 15mm from top of sidearm), which was later replaced with a 6 proximal xlt at a different hospital.On an unknown date, a laryngoscopy was performed, and some metal debris was remove via stoma with a hemostat.On (b)(6) 2018, the patient had a follow-up visit for tracheostomy care.During this visit a flexible tracheobronchoscopy was conducted through the tracheostomy tube.Wire mesh of the ultraflex stent was visible distal to the tracheostomy with mild overlying crusting which was non-obstructive.There was no bleeding noted.The procedure was tolerated well without complication.The patient was seen by a pain management specialist on (b)(6) 2019.
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Manufacturer Narrative
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The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Patient code 2371 captures the reportable event of disability.Patient code 3191 captures the reportable event of required intervention and surgery.Problem code 1069 captures the reportable event of stent break.Problem code 1528 captures the reportable event of stent difficult to remove.Problem code 3009 captures the reportable event of stent positioning problem.Problem code 4003 captures the reportable event of stent migration.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device remains implanted 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.(date of birth), (weight), (model number, lot number, catalog number, expiration date), (initial reporter first name), (premarket / 510(k) #), and (patient codes, device codes) have been corrected based off information noted on june 19, 2019.Note: (weight) is based on the patient weight as documented on november 25, 2013.
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Event Description
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It was reported to boston scientific corporation on (b)(6)2019 that an ultraflex tracheobronchial uncovered stent had been implanted to treat a benign stricture due to an allergic reaction to medication in (b)(4) or (b)(4).It was reported that the stent broke inside the patient on an unknown date.Reportedly, the patient has had over eighteen surgeries to try to remove the stent and has been transferred to multiple different hospitals; from memphis (where the stent was initially implanted) to nashville (vanderbilt medical center) then to boston (beth israel).Reportedly, the patient is now on a ventilator and disability due to damages related to the stent being left in place.Note: according to the complainant, the ultraflex tracheobronchial stent was placed for an allergic reaction.However, per ultraflex tracheobronchial stent system directions for use, the stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.Additional information noted on (b)(6)2019 according to medical records, in (b)(6)20192011, prior to placement of the ultraflex stent, the patient received hydralazine and developed anaphylaxis and upper airway swelling, requiring emergent tracheotomy.After eventual decannulation of the tracheostomy, a tracheal stenosis developed at the tracheostomy site.The ultraflex tracheobronchial uncovered stent was implanted on april 17, 2013, to treat this stricture.During the placement procedure, the stent was deployed at the level of the stenosis and forceps were used to move the stent up 4-5 mm so that there was complete coverage of the stenosis.According to the physician, the patient tolerated the procedure well.On an unknown date post stent placement, the patient was diagnosed with a tracheal stenosis.On (b)(6)2013, a bronchoscopy was performed to assess the extent of the stenosis.Reportedly, the patient was experiencing shortness of breath and wheezing at this time.The bronchoscopy noted mild narrowing/mild compromise at the proximal aspect of the ultraflex stent.The stent lumen and distal trachea were free of obstruction.The patient tolerated the procedure well without complication.A microlaryngoscopy with laser and bronchoscopy was planned for (b)(6)2013.The results of this procedure are unknown.On (b)(6)2013, the patient underwent a tracheoscopy with tracheal dilatation.Reportedly, the patient was experiencing worsening dyspnea, and a core needle evaluation revealed narrowing at the proximal limb of the tracheal stent.The dilatation was uneventful, and the airway appeared to be improved.Examination revealed granulation tissue with a moderate amount of stenosis above the level of the tracheal stent.There were no abnormalities at the distal end of the stent.Approximately 30% narrowing was appreciated in the superior aspect.The patient appeared to tolerate the procedure well without complications.The patient underwent a bronchoscopy with dilatation and granulation tissue removal on (b)(6)2013.On (b)(6)2013, the patient was admitted to the hospital from the er due to coughing up blood.This stopped the next morning.On (b)(6)2013, the patient complained of shortness of breath, thick mucous and dysphagia and did not feel that the prior dilatation had helped with their breathing.Reportedly, the patient's dysphagia resolved after balloon dilation on (b)(6)2014.At this time, a computed tomography scan (ct) was done.On (b)(6)2014, it was noted that a review of history and imaging suggested that the ultraflex stent had migrated lower in the trachea and was not addressing the area of stenosis.The stenosis was 50% with tracheal diameter a little less than 1 cm at the worst point and 2cm or so below the cords.On (b)(6)2014, a rigid bronchoscopy was performed and the stent was unable to be removed.According to the physician, the post tracheotomy stenosis was not being treated by the stent.The narrowing was noted to be mild.On (b)(6)2014, it was reported that the patient's condition was unchanged, still with shortness of breath and a cough productive of yellow sputum.It was also noted that the patient had bad breath and had undergone frequent rounds of antibiotics.The patient underwent a rigid open tube bronchoscopy for stent revision and airway granulation/stenosis destruction with electrocautery.Intubation was difficult.Inspection with rigid tracheoscope showed tracheostomy site stenosis of 25%, with the lumen estimated to be 14mm.The proximal 1/3 of the stent was incorporated into the wall of the trachea, and some granulation tissue was noted distally.A cautery knife was used to remove some of the stenotic scar on the proximal edge of the stent and stent forceps were used to test how free the stent was.It was not free at all.Blunt tip cautery was used to treat the granulation on the distal end of the stent and the area of stenosis at the tracheostomy site was dilated to 18mm.The were no patient complications noted and the patient was stable at the conclusion of this procedure.Post procedure, it was noted that the patient did not have cp, wheezing or stridor.The patient was admitted after this procedure due to lack of transportation and was discharged on (b)(6)2014.A bronchoscopy with balloon dilation was performed no (b)(6)2014 and it was noted that there was no flow-limiting stenosis.On (b)(6)2016, the patient reported that the shortness of breath had gotten a bit worse over the last six months.The patient reported having a bronchoscopy (date of procedure unknown) and that the orifice was much smaller.The patient was coughing up a moderate amount of greenish sputum, and had no fever, chills, nausea, vomiting or abdominal pain.A physical exam revealed no stridor or wheeze present over the lungs and no stridor present over the site of tracheostomy.A bronschoscopy with dilation was performed on (b)(6)2016.On (b)(6)2016, a direct laryngoscopy and flexible bronchoscopy with removal of mesh/airway foreign body was performed.On december 30, 2016, a bronchoscopy with foreign body removal and complex tracheostomy stoma revision was performed.According to the physician, removal of the ultraflex stent is a delicate process that can only be done when the stent presents itself.Additional surgeries to help correct the tracheal stenosis were performed on the following dates: (b)(6) 2017 (b)(6) 2017 (b)(6)2017 (b)(6)2017 (b)(6) 2017 (b)(6) 2017 (b)(6)2017 (b)(6)2018 a flexible bronchoscopy was performed on (b)(6)2017.On (b)(6)2017, the patient was seen for a cough, occasional coughing up blood, wheezing, and to discuss the stent.On (b)(6)2018, the patient was seen for tracheostomy care and reported chronic pain, which the patient felt was related to the stent.A physical exam noted the patient was breathing well with no stridor, and no dyspnea on exertion (doe), retractions or air hunger.A fiberoptic endoscopy of the larynx, subglottis, and trachea was performed via the nare.Examination of the trachea noted that the prosthesis was well-seated, however wire mesh was visible distal to tracheostomy.The distal trachea/carina was patent with moderate dynamic collapse (tracheobronchomalacia) evident on cough.With the trach retracted, some granulation tissue and exposed wire of the stent was evident.There was no active bleeding, no mucopurulence, and no significant mucosal breakdown on either anterior or posterior tracheal walls.Examination of the subglottis noted that there was mild subglottic/proximal tracheal collapse above the current stomal site.The procedure was tolerated well without complication.There was no evidence of tracheoesophageal fistula nor tracheoinnominate fistula and there was no clinical evidence of active airway obstruction or active infection at the time of this exam.A ct of the neck was performed on (b)(6)2018 and noted long segment loss of tracheal superstructure with integration of the ultraflex stent into the distal cervical and thoracic trachea.It was also noted that the tracheostomy tube entered the trachea through the ultraflex stent.An exam on (b)(6)2018, noted that the patient was positive for cough and shortness of breath.It was also noted that the patient was seeing a physician who was, at intervals, removing pieces of the stent and that the patient had a recent admission with bleeding (bloody trach secretions).In the physician's opinion, the bloody trach secretions were likely due to the use of anticoagulants in the setting of exposed portions of the wire stent.The patient was admitted to the hospital from the emergency department on (b)(6) 2018.The patient was discharged on that date.On (b)(6) 2018, the patient reported that the episodes of bloody trach secretion began to increase as their anticoagulant prescription was modified.The patient reported no dyspnea, dysphagia, stridor, or any other complaints.A physical exam noted no bloody secretions from the trach apparent externally and no peristomal granulation tissue.The patient exhibited normal effort on humidified trach collar, equal chest rise, and no stridor or stertor.A fiberoptic endoscopy was performed and noted no active bleeding inside the airway and no mucus plugging.Previously visualized granulation tissue in the airway related to the ultraflex stent was significantly reduced.A flexible nasopharyngoscopy noted an ultraflex stent wire just distal to the tip of the tracheostomy tube, with some exposed free wire and surrounding granulation tissue.The area was noted to be irritated with no active bleeding.The procedure was tolerated well without complication.On an unknown date, the patient saw a thoracic surgeon, who performed a rigid bronchoscopy, esophagoscopy, and open neck exploration.There appeared to be a stomal stenosis due to cartilage collapse, and the esophagus was normal without evidence of constriction or tracheoesophageal fistula.During this procedure, there was an attempt to remove the stent through an open neck incision; however, the stent could not be removed under direct open visualization due to tight integration into the airway mucosa.The procedure was completed by placing a 14 mm t-tube (with the proximal limb cut 15mm from top of sidearm), which was later replaced with a 6 proximal xlt at a different hospital.On an unknown date, a laryngoscopy was performed, and some metal debris was remove via stoma with a hemostat.On (b)(6)2018, the patient had a follow-up visit for tracheostomy care.During this visit a flexible tracheobronchoscopy was conducted through the tracheostomy tube.Wire mesh of the ultraflex stent was visible distal to the tracheostomy with mild overlying crusting which was non-obstructive.There was no bleeding noted.The procedure was tolerated well without complication.The patient was seen by a pain management specialist on (b)(6)2019.**additional information received on (b)(6)2020** the patient was hospitalized for a week starting monday (b)(6)2019, reported that he had surgery, his airway is starting to close and is infected.(b)(6)2019 the patient was hospitalized, reported that "doctors feel that lack of oxygen is making heart work harder and kidneys to slow down".Between (b)(6)2019 and (b)(6)2019 (exact date not reported) the patient passed away.On (b)(6)2020, and autopsy examination was completed and the following was reported: findings: "patient had status post remote placement of tracheal stent for tracheal stenosis due to anaphylactoid reaction to generic hydralazine with emergent tracheostomy, clinical.Hypertensive atherosclerotic cardiovascular disease, with cardiomegaly with biventricular hypertrophy, 900 grams, myocardial fibrosis, microscopic and nephrosclerosis with bilateral renal cortical cysts.Right renal calculi was noted.He had morbid obesity with a body mass index - 45.0- 49.9.And hepatomegaly with fatty infiltration, 3000 grams." cause of death: "hypertensive atherosclerotic cardiovascular disease." contributory factors: "complications of tracheal stenosis due to tracheal stent placement due to anaphylactoid reaction to generic hydralazine.Morbid obesity." opinion: "internal examination showed evidence of stent fragments embedded into the trachea which was non-obstructed." evidence of remote medical attention: "there was evidence of status post tracheal stent placement.Portions of the stent were incorporated into the wall of the esophagus and was surrounded by diffuse hyperemia.There was no evidence of perforation." respiratory system: "the pleural surfaces were smooth and glistening.The pulmonary arteries were normally developed, patent and without thrombus or embolus.The upper and lower airways contained bloody mucoid secretions.The mucosal surfaces were unremarkable.The pulmonary parenchyma was grayish purple and diffusely congested." alimentary tract: "the tongue, esophagus.Stomach, small and large bowels, rectum and anus showed no lesions or abnormalities.The stomach contained no contents.The gastric mucosa was unremarkable.".
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Manufacturer Narrative
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Block h6: patient code 2371 captures the reportable event of disability.Patient code 3191 captures the reportable event of required intervention and surgery.Problem code 1069 captures the reportable event of stent break.Problem code 1528 captures the reportable event of stent difficult to remove.Problem code 3009 captures the reportable event of stent positioning problem.Problem code 4003 captures the reportable event of stent migration.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Problem code 2949 captures the reportable event of stent tissue overgrowth.Patient code 1802 captures the reportable event of death.Block h10: the complainant indicated that the device remains implanted 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.Block h11: blocks a2 (date of birth), a4 (weight), b2, b3, b5, b6, b7, d4 (model number, lot number, catalog number, expiration date), d6, e1 (initial reporter first name), g5 (premarket / 510(k) #), h4, and h6 (patient codes, device codes) have been corrected based off information noted on (b)(6)2019.Note: a4 (weight) is based on the patient weight as documented on (b)(6)2013.Blocks a2 (race), a4 (weight), b2, b5, h1 and h6 (patient codes, device codes) have been updated based off information received on (b)(6)2020.Note: a4 (weight) is based on patient weight as documented in autopsy report on(b)(6) 2019, the patient's weight had previously been documented as 275 lb.On (b)(6)2013.The autopsy report was completed by forensic pathologist-(b)(6), m.D.
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