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

Model Number M00564850

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Reported event of stent failure to expand.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 december 20, 2016 that an ultraflex tracheobronchial distal release covered stent was to be used in the trachea to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure,the physician was able to deploy the stent; however, the stent failed to expand.The physician attempted to dilate the stent with a balloon but was unsuccessful.The stent was removed using forceps and the procedure was completed with a different device.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 fully deployed ultraflex tracheobronchial stent and delivery system were returned for analysis.The stent was received fully expanded and within specifications.No other issues with the device were noted.The investigation could not confirm the reported event based on the condition of the returned device.However, taking all available information into consideration, the investigation concluded that the reported event was most probably due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex tracheobronchial distal release covered stent was to be used in the trachea to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure,the physician was able to deploy the stent; however the stent failed to expand.The physician attempted to dilate the stent with a balloon but was unsuccessful.The stent was removed using forceps and the procedure was completed with a different device.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: 6247886
• MDR Text Key: 64708713
• Report Number: 3005099803-2016-04141
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

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: 02/04/2018
• Device Model Number: M00564850
• Device Catalogue Number: 6485
• Device Lot Number: 18890772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2016
• 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
• Patient Age: 68 YR
• Patient Weight: 60