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

Model Number M00564760

Device Problems Material Integrity Problem (2978); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(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) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent implantation performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, when viewed endoscopically under a flexible scope, the stent failed to expand.A dilatation balloon catheter was used to expand the stent, but the stent remained compressed.The patient woke up from sedation, and the stent was coughed out.The stent was sent for cleaning and was examined.It was noted that one end of the stent appeared to be narrowed/ unexpanded and the stent cover was entangled/damaged.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.

Event Description

It was reported to boston scientific corporation on may 14, 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture in the left principal bronchus during a stent implantation performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, when viewed endoscopically under a flexible scope, the stent failed to expand.A dilatation balloon catheter was used to expand the stent, but the stent remained compressed.The patient woke up from sedation, and the stent was coughed out.The stent was sent for cleaning and was examined.It was noted that one end of the stent appeared to be narrowed/ unexpanded and the stent cover was entangled/damaged.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

A deployed and expanded ultraflex tracheobronchial covered distal release stent with retention suture was received for analysis; the delivery system and deployment suture were not returned.Visual examination identified no issues with the stent.The stent was measured to be within specifications.The reported event of stent failed to expand and stent cover damage were not confirmed; the stent was received fully expanded and no damage was identified with the stent cover.Taking all available information into consideration, the reported events were likely due to anatomical/ 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) confirmed that the device met all material, assembly and product specifications at the time of release to distribution.A search of the complaint database revealed that no other similar complaints exist for the specified batch.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7570191
• MDR Text Key: 110109440
• Report Number: 3005099803-2018-01725
• 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
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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: 11/15/2018
• Device Model Number: M00564760
• Device Catalogue Number: 6476
• Device Lot Number: 0019966837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 50