MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M00564840

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02714 and 3005099803-2017-02668 for the associated device information.It was reported to boston scientific corporation that two ultraflex tracheobronchial distal release covered stents were used during a stent placement procedure to treat a malignant stricture performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight but not tortuous.According to the complainant, during the procedure, the first stent (the subject of mfr.Report #3005099803-2017-02714) was partially deployed and the deployment suture could not be released further.The physician removed the first stent from the patient.A second ultraflex tracheobronchial stent (the subject of this report) was implanted to complete the procedure.On (b)(6) 2017, 19 days post stent placement, the stent was re-examined via x-ray as scheduled per protocol and it was noted that stent wires were broken.The physician plans to remove and replace the stent, however the removal procedure has not been scheduled yet.The physician noted that the patient had undergone radiation or chemotherapy while the stent had been implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Reporter name and address:(first name, last name, complainant name, complainant address, complainant city, initial reporter phone number) has been updated with corrected information received on september 18, 2017.

Event Description

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02714 for the associated device information.It was reported to boston scientific corporation that two ultraflex tracheobronchial distal release covered stents were used during a stent placement procedure to treat a malignant stricture performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight but not tortuous.According to the complainant, during the procedure, the first stent (the subject of mfr.Report #3005099803-2017-02714) was partially deployed and the deployment suture could not be released further.The physician removed the first stent from the patient.A second ultraflex tracheobronchial stent (the subject of this report) was implanted to complete the procedure.On (b)(6) 2017, 19 days post stent placement, the stent was re-examined via x-ray as scheduled per protocol and it was noted that stent wires were broken.The physician plans to remove and replace the stent, however the removal procedure has not been scheduled yet.The physician noted that the patient had undergone radiation or chemotherapy while the stent had been implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6835940
• MDR Text Key: 84306999
• Report Number: 3005099803-2017-02668
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2018
• Device Model Number: M00564840
• Device Catalogue Number: 6484
• Device Lot Number: 18816338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention