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

Model Number M00564770

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

Device component code relates to problem code for the reported event of stent failure to expand.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant pulmonary airway stenosis during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement procedure.According to the complainant, during the procedure, the stent deployment suture was fully released but the stent failed to expand.The physician checked the stent with the scope and found the stent was ¿oppressed by the tracheal membrane¿.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchial stent.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 delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found several kinks at the distal end of the shaft.No other issues with the device were noted.The reported event was unable to be confirmed; the stent was not returned.The damage noted on the returned device is consistent with excessive force being to the delivery system.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure are likely 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 review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant pulmonary airway stenosis during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement procedure.According to the complainant, during the procedure, the stent deployment suture was fully released but the stent failed to expand.The physician checked the stent with the scope and found the stent was ¿oppressed by the tracheal membrane¿.The stent was removed with forceps and the procedure was completed with another ultraflex tracheobronchial stent.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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7523913
• MDR Text Key: 108604085
• Report Number: 3005099803-2018-01547
• 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: 04/27/2018

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: 11/27/2019
• Device Model Number: M00564770
• Device Catalogue Number: 6477
• Device Lot Number: 21432378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2017
• 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: 55 YR
• Patient Weight: 55