MAUDE Adverse Event Report: COOK INC UNKNOWN; JCT PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Death (1802); Hemoptysis (1887); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Date unknown patient expired due to hemoptysis (b)(6).(b)(4).The event is currently under investigation.

Event Description

As stated in the journal article: "efficacy and complications of the gianturco-z tracheobronchial stent for malignant airway stenosis, cardiovascular and interventional radiology.1999 jul-aug;22(4):287-92.Several events were noted.It is unknown if the events are related to the same patient.Please see the following details: "a (b)(6) man with lung carcinoma who suffered from recurrence and narrowing of the left main bronchus.A g-z stent 6cm long and 12mm in diameter was inserted, followed by 76 gy of external irradiation combined with bronchial arterial infusion chemotherapy and multiple endoluminal laser treatments.Six month later, he complained of the symptoms of bronchoesophageal fistula.Bronchoscopy demonstrated tumor ingrowth within the bronchial stent.A covered esophageal wallstent was used for treatment of the bronchoesophageal fistula and a bare wallstent for ingrowth in the left main bronchus.During this 6 months the upper two sections of stent struts had migrated into the mediastinum following separation of the nylon suture (arrows).The symptoms related to the bronchoesophageal fistula improved immediately after the procedure and dyspnea was also improved.However, the patient experienced massive hemoptysis and died 24hr after wallstent placement." ((b)(4); 1820334-2016-00955) "four patients suffered from increased thick secretions requiring multiple suctioning and aspiration by bronchoscopy.One of these patients died from asphyxiation 2 weeks after placement." ((b)(4); 1820334-2016-00958) "stent disruption and/or migration was observed in six patients.Of these six, four experienced life-threatening hemoptysis; all four had received aggressive anticancer treatment." ((b)(4); 1820334-2016-00959) "a plain chest radiograph demonstrates obstruction of the right main bronchus and narrowing of the lower trachea and left main bronchus.Three 20-mm g-z stents were placed in the lower trachea to the left main bronchus.Immediately after stent placement, the symptoms disappeared.Two days later, bronchial secretions increased, and he complained again of dyspnea despite multiple bronchial suctioning.Bronchoscopy demonstrated tumor ingrowth.Following laser therapy and chemotherapy, the patient's symptoms improved.Follow-up plain chest radiograph 10 weeks later, when the patient presented with a fever, shows an appearance of air density of the right pleural space secondary to an air leak from the tracheobronchial system, and migration of a tracheal stent strut (arrows).He died from massive hemoptysis 1 week later." ((b)(4); 1820334-2016-00956).

Manufacturer Narrative

(b)(4).Product has not been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.

Event Description

As stated in the journal article: "efficacy and complications of the gianturco-z tracheobronchial stent for malignant airway stenosis, cardiovascular and interventional radiology.1999 jul-aug;22(4):287-92.Several events were noted.It is unknown if the events are related to the same patient.Please see the following details: "a (b)(6) man with lung carcinoma who suffered from recurrence and narrowing of the left main bronchus.A g-z stent 6cm long and 12mm in diameter was inserted, followed by 76 gy of external irradiation combined with bronchial arterial infusion chemotherapy and multiple endoluminal laser treatments.Six month later, he complained of the symptoms of bronchoesophageal fistula.Bronchoscopy demonstrated tumor ingrowth within the bronchial stent.A covered esophageal wallstent was used for treatment of the bronchoesophageal fistula and a bare wallstent for ingrowth in the left main bronchus.During this 6 months the upper two sections of stent struts had migrated into the mediastinum following separation of the nylon suture (arrows).The symptoms related to the bronchoesophageal fistula improved immediately after the procedure and dyspnea was also improved.However, the patient experienced massive hemoptysis and died 24hr after wallstent placement." (pr (b)(4); 1820334-2016-00955) "four patients suffered from increased thick secretions requiring multiple suctioning and aspiration by bronchoscopy.One of these patients died from asphyxiation 2 weeks after placement." ((b)(4); 1820334-2016-00958) "stent disruption and/or migration was observed in six patients.Of these six, four experienced life-threatening hemoptysis; all four had received aggressive anticancer treatment." ((b)(4); 1820334-2016-00959) "a plain chest radiograph demonstrates obstruction of the right main bronchus and narrowing of the lower trachea and left main bronchus.Three 20-mm g-z stents were placed in the lower trachea to the left main bronchus.Immediately after stent placement, the symptoms disappeared.Two days later, bronchial secretions increased, and he complained again of dyspnea despite multiple bronchial suctionings.Bronchoscopy demonstrated tumor ingrowth.Following laser therapy and chemotherapy, the patient's symptoms improved.Follow-up plain chest radiograph 10 weeks later, when the patient presented with a fever, shows an appearance of air density of the right pleural space secondary to an air leak from the tracheobronchial system, and migration of a tracheal stent strut (arrows).He died from massive hemoptysis 1 week later." (pr (b)(4); 1820334-2016-00956).

Manufacturer Narrative

Separate mdr's have been filed for the same article related to the following: patient death related to asphyxiation: mfr# 1820334-2016-00958.Stent migration, massive hemoptysis & death: mfr# 1820334-2016-00956.Stent migration & hemoptysis: mfr # 1820334-2016-00959.A review of the complaint history, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.The cook-z® tracheobronchial stent is intended for use in patients with extrinsic narrowing of the trachea and/or bronchus as a result of tumor encasement or compression in which other interventional techniques did not give satisfactory results.The stent has been designed to maintain patency of stenosed trachea or bronchus due to extrinsic compression caused by a tumor.It is indicated as a palliative measure particularly for patients with end stage malignant airway obstruction.Use of metallic tracheal stents may preclude the success of subsequent surgical procedures and should be considered only for patients after all alternative therapies have been exhausted.Contraindications include patients who will require repeated endotracheal laser treatments.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be conclusively determined.Per the quality engineering risk assessment no further action is required.Monitoring will continue to be performed for similar complaints.

Event Description

As stated in the journal article: "efficacy and complications of the gianturco-z tracheobronchial stent for malignant airway stenosis, cardiovascular and interventional radiology.1999 jul-aug;22(4):287-92.Several events were noted.It is unknown if the events are related to the same patient.Please see the following details: "a (b)(6) old man with lung carcinoma who suffered from recurrence and narrowing of the left main bronchus.A g-z stent 6 cm long and 12 mm in diameter was inserted, followed by 76 gy of external irradiation combined with bronchial arterial infusion chemotherapy and multiple endoluminal laser treatments.Six month later, he complained the symptoms of bronchoesophageal fistula.Bronchoscopy demonstrated tumor ingrowth within the bronchial stent.A covered esophageal wall stent was used for treatment of the bronchoesophageal fistula and a bare wall stent for ingrowth in the left main bronchus.During this 6 months the upper two sections of stent struts had migrated into the mediastinum following separation of the nylon suture (arrows).The symptoms related to the bronchoesophageal fistula improved immediately after the procedure and dyspnea was also improved.However, the patient experienced massive hemoptysis and died 24hr after wall stent placement.".

• Brand Name: UNKNOWN
• Type of Device: JCT PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5947479
• MDR Text Key: 54627387
• Report Number: 1820334-2016-00955
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/12/2016; 06/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR