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

Model Number M00564760

Device Problems Difficult to Remove (1528); Activation Failure (3270)

Patient Problem Pneumonia (2011)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

Reported event of catheter difficult to remove.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

Note: this report pertains to one of three devices used within the same patient.Refer to manufacturer report 3005099803-2015-03216, 3005099803-2015-03217 and 3005099803-2015-03218 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2015 that three ultraflex tracheobronchial stents were implanted to treat a 2cm stricture due to lung cancer in the right upper lobe during a bronchial stent implantation procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to stent placement.During the procedure, the physician fully deployed the first ultraflex tracheobronchial stent (the subject of this report); however, the stent did not fully expand inside the patient.The physician removed the delivery system but the stent came out together with the delivery system.The physician attempted to fully deploy the stent outside the patient but it did not fully expand.The physician attempted to implant a second ultraflex tracheobronchial stent (the subject of mfr report # 3005099803-2015-03217); however, when the stent was deployed approximately 5 mm from the distal side, the suture got stuck and failed to completely deploy the stent.The stent was removed from the patient partially deployed.Once the device was removed, the physician attempted to deploy the stent and the stent was able to be fully deployed outside the patient.The third ultraflex tracheobronchial stent (the subject of mfr report # 3005099803-2015-03218) was fully deployed inside the patient; however, the stent failed to completely expand.During removal, the distal tip of the delivery system got stuck within the stent and the stent came out together with the delivery system.The procedure was completed with another ultraflex tracheobronchial stent.It was reported that the patient experienced pneumonia.In the physician's assessment, the pneumonia occurred due to prolonged procedure time and not due to the stent issues.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

An ultraflex tracheobronchial stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was deployed from the delivery device.An examination of the stent found that the stent had not fully expanded.The maximum stent outer diameter (od) was measured at 8mm, which was below the product specification of 10.0mm ±1.5mm.The stent was equilibrated in 37°c water for 15 minutes; however, the stent did not expand any further.A visual and tactile examination of the catheter found no kinks or damage along the length of the shaft.No other issues were identified during the product analysis.The actual pull-ring section of the device was not received for analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

Note: this report pertains to one of three devices used within the same patient.Refer to manufacturer report 3005099803-2015-03216, 3005099803-2015-03217 and 3005099803-2015-03218 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2015 that three ultraflex tracheobronchial stents were implanted to treat a 2cm stricture due to lung cancer in the right upper lobe during a bronchial stent implantation procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was not tortuous and had not been dilated prior to stent placement.During the procedure, the physician fully deployed the first ultraflex tracheobronchial stent (the subject of this report); however, the stent did not fully expand inside the patient.The physician removed the delivery system but the stent came out together with the delivery system.The physician attempted to fully deploy the stent outside the patient but it did not fully expand.The physician attempted to implant a second ultraflex tracheobronchial stent (the subject of mfr report # 3005099803-2015-03217); however, when the stent was deployed approximately 5 mm from the distal side, the suture got stuck and failed to completely deploy the stent.The stent was removed from the patient partially deployed.Once the device was removed, the physician attempted to deploy the stent and the stent was able to be fully deployed outside the patient.The third ultraflex tracheobronchial stent (the subject of mfr report # 3005099803-2015-03218) was fully deployed inside the patient; however, the stent failed to completely expand.During removal, the distal tip of the delivery system got stuck within the stent and the stent came out together with the delivery system.The procedure was completed with another ultraflex tracheobronchial stent.It was reported that the patient experienced pneumonia.In the physician's assessment, the pneumonia occurred due to prolonged procedure time and not due to the stent issues.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: 5221454
• MDR Text Key: 31072945
• Report Number: 3005099803-2015-03216
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• 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: 10/20/2015

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: 07/21/2016
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 17141116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2014
• 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