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

Model Number M00564800

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

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 device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex¿ tracheobronchial distal release covered stent was implanted in the tracheal bronchus to treat a malignant stricture during stent placement procedure performed on (b)(6) 2017.Reportedly, patient's anatomy was tight.According to the complainant, during the procedure, the stent was successfully deployed.However, the physician reported that the stent did not fully expand after deployment.Few hours post implantation, the patient coughed and the stent was expectorated outside the body.On (b)(6) 2017, another ultraflex tracheobronchial stent was 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

Investigation results: a deployed ultraflex tracheobronchial covered stent was received for analysis, the delivery system was not returned.The stent was measured to be within specifications.No issues were identified with the device.The investigation could not confirm the reported event that the stent failed to expand based on the condition of the returned device.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.Additionally, stent migration is noted within the dfu as a potential complication.The dfu also states ¿optional: if necessary, complete stent expansion using balloon dilators up to the diameter of the stent.¿ taking all available information into consideration, the investigation concluded that the event is due to a known physiological effect of the procedure noted within the directions for use and/or device labeling.Therefore, the most probable root cause assigned for this event is anticipated procedural complication.A review of the device history record (dhr) revealed no non-conforming events or deviations.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex¿ tracheobronchial distal release covered stent was implanted in the tracheal bronchus to treat a malignant stricture during stent placement procedure performed on (b)(6) 2017.Reportedly, patient's anatomy was tight.According to the complainant, during the procedure, the stent was successfully deployed.However, the physician reported that the stent did not fully expand after deployment.Few hours post implantation, the patient coughed and the stent was expectorated outside the body.On (b)(6) 2017, another ultraflex tracheobronchial stent was 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: 6633035
• MDR Text Key: 77283572
• Report Number: 3005099803-2017-01767
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2018
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 19299097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 07/07/2017
• Supplement Dates FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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